Aquamantys User
Aquamantys User
ii
USER GUIDE
iii
Foreword
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 Aquamantys Pump Generator Service Manual
and 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.
Precaution: Federal (USA) Law restricts this device to sale, distribution and use by or on the order of a
physician.
Customer Service:
Tel: 866.777.9400
+1.603.742.1515 (outside the U.S.)
Fax: 866.222.0900
+1.603.742.1488 (outside the U.S.)
E-mail: customerservice@tissuelink.com
iv
Table of Contents
Foreword...................................................................................................................................................................... iv
Table of Contents.......................................................................................................................................................... v
List of Figures............................................................................................................................................................... vi
Introduction ..................................................................................................................................................................1-1
Indications for Use .....................................................................................................................................................1-1
Features .....................................................................................................................................................................1-2
RF Power ...................................................................................................................................................................1-2
Simultaneous RF Power and Saline Delivery.............................................................................................................1-2
Saline Flow Rate Setting............................................................................................................................................1-2
Priming.......................................................................................................................................................................1-3
Controls, Indicators, and Receptacles .......................................................................................................................2-1
Symbols .....................................................................................................................................................................2-5
Patient and Operating Room Safety ...........................................................................................................................3-1
General ......................................................................................................................................................................3-1
Confirm Proper Connections ......................................................................................................................................3-1
Power Cords ..............................................................................................................................................................3-2
Servicing ....................................................................................................................................................................3-2
Before Surgery ...........................................................................................................................................................3-2
During Surgery ...........................................................................................................................................................3-3
Do Not Use Other (Non-Aquamantys) Devices ..........................................................................................................3-3
After Surgery ..............................................................................................................................................................3-3
Before Surgery .............................................................................................................................................................4-1
Quick Setup Instructions ............................................................................................................................................4-1
Setting Up the AquamantysTM Pump Generator.........................................................................................................4-1
Preparing for Surgery.................................................................................................................................................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............................................4-3
Spiking the Saline Bag ...............................................................................................................................................4-6
Priming the Aquamantys™ Disposable Bipolar Device..............................................................................................4-6
Adjusting the RF Power Setting .................................................................................................................................4-8
Adjusting the Saline Flow Rate ..................................................................................................................................4-8
During Surgery .............................................................................................................................................................5-1
Checking the Aquamantys™ Disposable Bipolar Device Connection ........................................................................5-1
Changing the RF Power Setting.................................................................................................................................5-1
Changing the Saline Flow Rate Setting......................................................................................................................5-2
Activating the Aquamantys™ System ........................................................................................................................5-2
Adjusting the Volume of the Activation Tone..............................................................................................................5-3
Responding to Alarms................................................................................................................................................5-3
After Surgery ................................................................................................................................................................6-1
Disposing of the Aquamantys™ Bipolar Device .........................................................................................................6-1
Preparing the Aquamantys™ Pump Generator for Reuse .........................................................................................6-1
Transportation and Storage of the Aquamantys™ Pump Generator..........................................................................6-1
Troubleshooting ...........................................................................................................................................................7-1
General Troubleshooting Guidelines..........................................................................................................................7-1
Troubleshooting Malfunctions ....................................................................................................................................7-2
Responding to Alarms................................................................................................................................................7-6
Maintenance and Repair ..............................................................................................................................................8-1
Responsibility of the Manufacturer .............................................................................................................................8-1
Routine Maintenance .................................................................................................................................................8-1
Returning the Aquamantys™ Pump Generator for Service........................................................................................8-2
Technical Specifications............................................................................................................................................. A-1
Performance Characteristics ..................................................................................................................................... A-1
Standards and IEC Classifications ............................................................................................................................ A-4
Output Characteristics............................................................................................................................................... A-5
Accessories............................................................................................................................................................... A-8
Warranty....................................................................................................................................................................... B-1
v
List of Figures
vi
Section 1
Introduction
This section contains information about:
• Indications for Use
• RF Power
• Simultaneous RF Power and Saline Delivery
• Saline Flow Rate Setting
• Priming
Warnings: The system is not intended for contraceptive tubal coagulation (permanent female
sterilization).
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 TissueLink Medical and
use another Aquamantys disposable bipolar device or replace the Aquamantys Pump
Generator.
Consult the operating and user manuals for light sources and other ancillary devices
for warnings, precautions, and instructions prior to their use with the Aquamantys
System.
1-1
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.
Precautions: Read all warnings, precautions, and instructions provided with the Aquamantys Pump
Generator before using.
Special care should be taken when using the Aquamantys System in the proximity of
neural tissue.
Position the Aquamantys Pump Generator away from life supporting and/or
monitoring systems to reduce/avoid interference with these systems.
If the 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
• 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.
1-2
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.
Precaution: 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.
1-3
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.
10
11
1
3
2 4 5 6 7 8
Figure 2-2. Rear Panel
2-1
1 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
“ } ”. It is recommended that the unit be switched off when it is not intended
to be used for an extended period of time.
2 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).
Precautions: 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. Pressing
the button a third time will reset the timer and restart the priming cycle from the
beginning.
2-2
8 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.
Warning: 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.
Precaution: 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.
12 Loudspeaker
13 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.
Warning: Do not place adhesive tape or any other muffling device over the loudspeaker.
14 Name Plate
This plate specifies the model number, serial number, nominal line voltages,
frequency, current, and fuse rating information for the Aquamantys Pump
Generator.
1 5 Fuse Drawer
This fuse drawer contains two fuses. The Aquamantys Pump Generator
Service Manual contains information for changing fuses.
2-3
16 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.
2-4
Symbols
Several symbols appear on the Aquamantys Pump Generator front panel, rear panel, and pump head.
Bipolar Device
CE Mark
Activates/deactivates device
priming sequence
2-5
Section 3
Patient and Operating Room Safety
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.
General
Warnings: Use the Aquamantys System with caution in the presence of pacemakers, as
electrosurgical equipment may cause interference with pacemakers or other 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.
Precautions: Read all warnings, precautions, and instructions provided with the Aquamantys Pump
Generator before using.
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 unintended thermal damage to tissue.
Do not attempt to alter device configurations or replace device components with non-
standard parts since this may result in decreased device performance, device
malfunction, or patient injury.
• 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.
Servicing
Warnings: Electric Shock Hazard Do not remove the Pump Generator bottom cover. Removal
of the bottom cover voids any warranty. Contact authorized personnel for service.
Precautions: The Aquamantys Pump Generator should only be serviced by a qualified technician
according to your hospital’s capital equipment servicing guidelines. TissueLink
Medical recommends that the unit be recalibrated and undergo a safety check by a
qualified service technician on an annual basis.
Before Surgery
Aquamantys Disposable Bipolar Devices are sterile, 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.
Warnings: Electric Shock Hazard Ensure that the device is correctly connected.
Precautions: 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.
Electrical Shock Hazard Connect the Aquamantys Pump Generator power cord
directly to a properly grounded receptacle which provides the appropriate electrical
voltage and current.
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.
Precautions: 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.
3-2
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.
Connect the main power cord directly to a properly grounded receptacle which
provides the appropriate electrical voltage and current. Otherwise, product damage
may result.
During Surgery
Aquamantys™ Pump Generator Power Settings
Warnings: 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.
Precautions: Do not turn the activation tone down to an inaudible level. The activation tone alerts
the surgical team when a device is active.
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 electrosurgical generators could result in
injury to the patient or surgical team, or cause damage to the device and/or the
generator.
Precautions: 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.
After Surgery
Warnings: Electrical Shock Hazard Always turn off and unplug the Aquamantys Pump
Generator before cleaning.
Precautions: 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
This section contains information about preparing the Aquamantys Pump Generator
for surgery.
Precautions: Read all warnings, 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.
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 “}”.
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 self-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 the Aquamantys Service
Manual if an error code appears.
9. 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.
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 the Aquamantys Service Manual.
4-2
Preparing for Surgery
Warnings: Electric Shock Hazard Ensure that the device is correctly connected and that no
metal is exposed.
Precautions: Read the instructions, warnings, and precautions provided with the electrosurgical
device before 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.
Figure 4-1. Insert the device plug into the Aquamantys™ Pump Generator
The saline delivery tubing of the Aquamantys disposable bipolar device includes a
special pump 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.
4-3
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).
4-4
Figure 4-3. Placing the pump segment portion of the saline
delivery tubing into the 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 green electrical 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.
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
4-6
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.
Precautions: Always place the device into a holster or over a container to collect the 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 2nd time prior to priming cycle being
completed.
4-7
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.
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.
4-8
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-7 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.
4-9
Section 5
During Surgery
This section contains information about:
Precautions: Read all warnings, precautions, and instructions provided with this Aquamantys Pump
Generator before using.
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.
Confirm that the Aquamantys disposable bipolar device is properly connected to the
Aquamantys Pump Generator. Only one device can be connected at any one time.
Precautions: 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 U button to increase the RF power.
Press the V button to decrease the RF power.
5-1
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.
Set the saline flow rate setting by pressing the button next to the desired flow rate.
Flow rate options include:
The three possible saline flow rates are preset for each given power setting. See
Figure A-3 on page A-7 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.
Precautions: Use the Aquamantys disposable bipolar device only until you achieve the desired
tissue effect.
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
presence 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.
5-2
Adjusting the Volume of the Activation Tone
Precautions: 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 “} ”.
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 front panel LEDs will illuminate momentarily
and an audible tone test will sound.
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 the Aquamantys Service
Manual.
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 the Aquamantys Service Manual.
If you are unable to correct the malfunction, use a backup generator or traditional
hemostatic techniques to complete the surgical procedure.
5-3
Section 6
After Surgery
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
Precautions: 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.
Precautions: 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 the Aquamantys Pump Generator off by pressing the bottom portion of
the power switch marked “}”.
2. Unplug the main power cord from the wall outlet and receptacle on the Pump
Generator.
3. 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.
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 calibration verification before
use. Refer to the Aquamantys Pump Generator Service Manual.
Do not store the Aquamantys Pump Generator on its side or end. This may cause
damage to the unit.
6-1
Section 7
Troubleshooting
This section contains information about:
• General Troubleshooting Guidelines
• Troubleshooting Malfunctions
• Responding to Alarms
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.
Fuse drawer is open or fuses are blown. Close the fuse drawer. Replace the blown fuse(s).
Refer to the Service Manual.
Wrong fuse. Use fuse listed in Aquamantys Pump Generator
User Guide and/or Service Manual. 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. Ensure Aquamantys disposable bipolar device is
fully inserted into device plug receptacle.
Insufficient insertion of power cord into unit or wall jack. Ensure power cord is fully inserted into back of unit
and wall jack.
Damaged Aquamantys Pump Generator power cord. Contact TissueLink Medical Customer Service to
obtain a new power cord.
Damaged Aquamantys disposable bipolar device power Do not use device. Return the device to TissueLink
cord. Medical and use new device.
Internal component malfunction. Contact Biomedical Engineering Department or 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.
No saline when Pump tubing segment not inserted correctly into pump Remove pump tubing segment from pump head
device activated head. and reinsert correctly as indicated in User Guide.
Saline bag positioned on side or upside down. Ensure saline bag is positioned right side up.
Pump head not closed. 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 (0.9%NaCI).
Priming cycle not completed. Press “START PRIME” button once and ensure
priming cycle completes and saline drips from both
electrodes of the device.
Priming button on unit pressed before the saline bag Press “START PRIME” button once and ensure
was spiked. 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%NaCI) with a new bag.
7-2
Situation Possible Cause Solution
No saline when Pump tubing segment inserted in reverse Ensure black connector on the Aquamantys
device activated orientation. disposable bipolar device pump tubing segment is
(continued) 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 Ensure device connected to Pump Generator is an
Pump Generator. 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 TissueLink Medical 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 Open vent cap on Aquamantys disposable bipolar
bottle. device drip chamber.
Incorrect saline flow Pump tubing segment not inserted correctly into Remove pump tubing segment from pump head
when device pump head. and reinsert correctly as indicated in User Guide.
activated
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 Remove pump tubing segment from pump head
instead of pump tubing segment. and reinsert correctly as indicated in User Guide.
Ensure black connector on the Aquamantys
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 the
technique. 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 an
utilized. Aquamantys device (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 precautions are taken to avoid inadvertent device
device clogged by tissue or coagulated blood. activation when cleaning device electrode. If this
does not correct the problem, return device to
TissueLink Medical 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
Situation Possible Cause Solution
Generator doesn’t Pump Generator damaged. Contact Biomedical Engineering Department or a
work 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.
Pump Generator did not receive a scheduled safety Contact Biomedical Engineering Department or a
check. 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. See Aquamantys Service
Manual for maintenance schedule.
Pump Generator plugged into an inappropriate wall Plug Pump Generator into an appropriate wall
outlet (e.g. not protected against ground fault, etc.). outlet prior to use.
Unit is on, but did Software or internal component malfunction. Turn off, and then turn on the unit. If the error
not complete self- code reappears:
test. • 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.
Unit is on and Power setting is too low. Increase the power. Refer to Section 5, Changing
disposable device the RF Power Setting. Use the lowest possible
is activated, but power setting needed to obtain the desired
unit does not surgical effect.
deliver output.
Malfunctioning Aquamantys disposable bipolar device or Turn off the unit. Check the device connection. If
improper device connection. device continues to malfunction, replace device
and contact TissueLink Medical to report device
malfunction.
A malfunction condition exists. Check the power display for an error code. Note
the code number and refer to Responding to
Alarms in this section.
Internal component malfunction. Use a backup Pump Generator or traditional
hemostatic techniques to complete the surgical
procedure. Contact your Biomedical Engineering
Department or a TissueLink representative for
assistance.
Interference with Metal-to-metal sparking. Check all connections to the unit and device.
other device only
when the unit is Electrically inconsistent ground wires in the operating Verify that all ground wires are as short as
activated. room. possible and go to the same grounded metal.
Continuous Faulty chassis-to-ground connections. Check and correct the chassis ground connections
monitor for the monitor and for the unit.
interference.
Monitor responding to radiated frequencies. Check other electrical equipment in the room for
defective grounds. If not resolved, contact
Biomedical Engineering Department to check with
the monitor manufacturer.
7-4
Situation Possible Cause Solution
Abnormal Metal-to-metal sparking. Check all connections to the unit and devices.
neuromuscular
stimulation
(Stop surgery
immediately)
Ineffective Power setting too low. Increase the power. Refer to Section 5, Changing
hemostasis the RF Power Setting. Use the lowest possible
power setting needed to obtain the desired surgical
effect.
Tissue under-treated. Tissue not treated long See Aquamantys disposable bipolar device
enough to result in a reduction in intraoperative or Instructions For Use and/or device treatment guides
postoperative blood loss. for treatment recommendations.
Wrong fluid used for device irrigation. Only utilize sterile bag of sodium chloride solution
(0.9%NaCI) with the Aquamantys System.
Electrode(s) of Aquamantys disposable bipolar Clean device electrodes with gauze. Ensure
device clogged by tissue or coagulated blood. precautions are taken to avoid inadvertent device
activation when cleaning device electrodes. If this
does not correct the problem, return device to
TissueLink and use new device.
Excessive blood, fluid or saline in surgical field Utilize appropriate suction to remove blood, fluid
where device is being utilized. and/or saline. See Aquamantys disposable bipolar
device instructions for use and/or device treatment
guides for treatment recommendations.
Unintended tissue Power setting too high. Decrease the power. Refer to Section 5, Changing
effect 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. 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.
Excessive saline Saline flow rate setting too high. Decrease saline flow rate. Refer to Section 5,
Changing the Saline Flow Rate Setting.
Excess saline resulting from 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.
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. 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.
Saline delivery tubing inserted into pump head Remove pump segment from pump head and
instead of pump tubing segment. reinsert correctly as indicated in User Guide. 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.
Pump head disengaged following procedure prior to The Aquamantys disposable bipolar device and the
firmly knotting the saline delivery tubing between saline bag will contain unused saline following use of
the drip chamber and the pump segment on the the device. Firmly knot the saline delivery tubing
device. between the drip chamber and the pump segment on
the device prior to opening the pump head.
Error codes Error codes appear. Turn power off for a minimum of 10 seconds, turn
power back on. If error code still displays, contact
TissueLink Medical.
7-5
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. Turn the Aquamantys Pump Generator off by pressing the bottom portion of
the power switch marked “ } ”.
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 front panel LEDs will illuminate momentarily and an
audible tone test will sound.
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 the Aquamantys Service
Manual.
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, turn the unit off, unplug the Aquamantys
disposable bipolar device from the unit (if applicable), and then turn the unit back on
to cycle it through the self-test. If this resolves the problem, return the original
Aquamantys disposable bipolar device to TissueLink Medical and open a new device
for the procedure.
If the above steps do not resolve the problem, do not attempt to use the Aquamantys
Pump Generator and refer to the Aquamantys Service Manual.
If you are unable to correct the malfunction, use a backup Pump Generator or
traditional hemostatic techniques to complete the surgical procedure.
7-6
Section 8
Maintenance and Repair
This section contains information about:
• Routine maintenance
• Returning the unit for service
For warranty information, refer to the Warranty at the end of this guide.
Routine Maintenance
Precautions: Refer to the Aquamantys Pump Generator Service Manual for maintenance
recommendations, safety check information, and function/output power verification
procedures.
8-1
Returning the Aquamantys™ Pump Generator for Service
Before you return the unit, call your TissueLink Medical representative 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.
The unit should be cleaned prior to shipping and shipped in an appropriate packaging
which protects the unit from damage (see below).
Precautions: 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 allow fluids to enter the chassis. The unit cannot be sterilized.
Follow the shipping instructions provided while obtaining the Return Goods
Authorization number.
8-2
Appendix A
Technical Specifications
Performance Characteristics
General
Operating Parameters
Duty Cycle
At maximum output settings (200 Watts) and rated load conditions (100 Ohms) the
unit may be safely operated 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
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 meets the electromagnetic compatibility
requirements of IEC60601-1-2:2001.
A-2
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.
A-3
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.
Drip Proof
This unit enclosure is constructed so that liquid spillage in normal use does not wet
IPX1 electrical insulation or other components which, when wet, are likely to affect
adversely the safety of the unit.
Electromagnetic Compatibility
This unit complies with the appropriate IEC 601-1-2 and 601-2-2 specifications
regarding electromagnetic compatibility.
A-4
Output Characteristics
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
Output Waveform
Bipolar 370 kHz sinusoid
All specifications are valid for software version 1.11 and below.
A-5
Figure A-1. Output Voltage vs. Power Setting
250
200
150
Voltage
100
50 Bipolar Vpk
Bipolar Vrms
0
20 40 60 80 100 120 140 160 180 200
Power Setting (Watts)
250
Bipolar Power @ 200 Watt Setting
200 Bipolar Power @100 Watt Setting
Power (Watts)
150
100
50
0
0 100 200 300 400 500 600 700 800 900 1000
Load (Ohms)
A-6
Figure A-3. Saline Flow Rate vs. Power Setting
32
28 High
Saline Flow Rate (cc/min) Medium
24 Low
20
16
12
0
20 40 60 80 100 120 140 160 180 200
Power Setting (Watts)
250
Output Power (Watts)
200
150
100
50
0
0 25 50 75 100 125 150 175 200
A-7
Accessories
Aquamantys™ System Power Cords
A-8
Appendix B
New Unit Warranty
For one (1) year from the date of shipment from TissueLink Medical, Inc., 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. 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.
For six (6) months from the date of shipment from TissueLink, if a refurbished
Aquamantys Pump Generator is found, to TissueLink’s satisfaction, to be
inoperable during normal and proper use in accordance with applicable instructions,
TissueLink Medical, 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.
B-1
B-2
TissueLink Medical, Inc.
Suite 400
One Washington Center
Dover, NH 03820
USA
www.tissuelink.com
www.aquamantys.com
Customer Service:
Tel: 866.777.9400
+1.603.742.1515 (outside the U.S.)
Fax: 866.222.0900
+1.603.742.1488 (outside the U.S.)
© Copyright 2005-2007 TissueLink Medical, Inc. All rights reserved. Printed in USA. TISSUELINK,
the TISSUELINK LOGO, SIMPLY BETTER SURGERY, AQUAMANTYS, and the AQUAMANTYS LOGO are
trademarks of TissueLink Medical, Inc. Additional trademarks are the property of their respective owners.
70-10-1061 Rev J
B-3