MC-55-097-001 r2 DRE ASG 300 UG-E
MC-55-097-001 r2 DRE ASG 300 UG-E
Distributed by:
DRE, Inc.
1800 Williamson Court
Louisville, KY 40223
©2013 DRE, Inc. All rights reserved. Contents of this publication may not be reproduced without the written permission of
DRE, Inc.
CAUTION:
Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
NOTICE:
Indicates an operating tip, a maintenance suggestion, or a hazard that may result in product
damage.
iv 800-477-2006 • www.dremed.com
Troubleshooting ....................................................................................................................6-1
Repair Policy and Procedures .............................................................................................7-1
Responsibility of the Manufacturer..................................................................................7-2
Returning the Generator for Service ...............................................................................7-2
Step 1 – Obtain a Return Merchandise Authorization Number...............................7-2
Step 2 – Clean the Generator .................................................................................7-2
Step 3 – Ship the Generator ...................................................................................7-2
Technical Specifications......................................................................................................A-1
Performance Characteristics...........................................................................................A-2
Input Power.............................................................................................................A-2
Duty Cycle...............................................................................................................A-2
Dimensions and Weight ..........................................................................................A-2
Operating Parameters.............................................................................................A-2
Transport and Storage ............................................................................................A-2
Audio Volume..........................................................................................................A-3
Return Electrode Sensing.......................................................................................A-3
Low Frequency (50-60 Hz) Leakage Current .........................................................A-3
High Frequency (RF) Leakage Current ..................................................................A-4
Standards and IEC Classifications .................................................................................A-4
Class I Equipment (IEC 60601-1)...........................................................................A-4
Type CF Equipment (IEC 60601-1) / Defibrillator Proof .........................................A-4
Drip Proof (IEC 60601-2-2).....................................................................................A-4
Electromagnetic Interference ..................................................................................A-4
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......................A-4
Voltage Transients (Emergency Generator Mains Transfer) ..................................A-4
Output Characteristics ....................................................................................................A-5
Maximum Output for Monopolar and Bipolar Modes..............................................A-5
EMC Compliance............................................................................................................A-5
Output Power Curves .....................................................................................................A-9
Warranty ................................................................................................................................B-1
vi 800-477-2006 • www.dremed.com
INTRODUCING THE ASG-300
This section includes the following information:
● Key Features
● Safety
Cautions:
Read all warnings, cautions, and instructions provided with this generator before using.
Read the instructions, warnings, and cautions provided with electrosurgical accessories before
using. Specific instructions are not included in this manual.
• Presets
The surgeon can store 10 user-defined presets for easy recall of frequently used settings.
Notices:
The Bovie NEM™ system recommends that you use a split return electrode.
Before activation, pad placement and visual verification of the split return electrode (split pad) indi-
cator on the front panel is recommended. After connecting the split pad to the generator and plac-
ing the split pad securely to the patient, give the unit 5 to 10 seconds to recognize the split pad.
The split pad indicator will illuminate green. If the split pad and cord are attached to the generator
without secure contact to the patient, the alarm indicator will illuminate red.
• Memory
The unit automatically powers up to the last selected preset settings.
• Isolated RF output
This minimizes the potential of alternate site burns.
• Standard connectors
These connectors accept the latest monopolar and bipolar instruments. Refer to Section 2, Controls, Indicators, and Receptacles to
learn more.
• ASG-300
• User’s Guide
Physicians have used electrosurgical equipment safely in numerous procedures. Before starting any surgical procedure, the surgeon
should be familiar with the medical literature, complications, and hazards of using electrosurgery in that procedure.
To promote the safe use of the ASG-300, this section presents the warnings and cautions that appear throughout this user’s guide. It
is important that you read, understand, and follow the instructions in these warnings and cautions so that you can operate this
equipment with maximum safety. It is also important that you read, understand, and follow the instructions for use in this
user’s guide.
warnings:
HazardousElectricaloutput - This equipment is for use only by trained, licensed physicians.
Danger:Fire/ExplosionHazard - Do not use the ASG-300 in the presence of flammable
materials.
Fire/ExplosionHazard - The following substances will contribute to increased fire and explosion
hazards in the operating room:
• Flammable substances (such as alcohol based skin prepping agents and tinctures)
• Naturally occurring flammable gases which may accumulate in body cavities such as
the bowel
• Oxygen enriched atmospheres
• Oxidizing agents (such as nitrous oxide [N20] atmospheres).
The sparking and heating associated with electrosurgery can provide an ignition source.
Observe fire precautions at all times. When using electrosurgery in the same room with any
of these substances or gases, prevent their accumulation or pooling under surgical drapes, or
within the area where electrosurgery is performed.
Connect the power cord to a properly polarized and grounded power source with the frequency
and voltage characteristics that match those listed on the back of the unit.
ElectricshockHazard - Connect the generator power cord to a properly grounded receptacle.
Do not use power plug adapters.
ElectricshockHazard - Always turn off and unplug the generator before cleaning.
FireHazard - Do not use extension cords.
Patientsafety - Use the generator only if the self-test has been completed as described.
Otherwise, inaccurate power outputs may result.
Failure of the high frequency electrosurgical equipment could result in an unintended increase of
output power.
The instrument receptacles on this generator are designed to accept only one instrument at a
time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing
so will cause simultaneous activation of the instruments.
Use the lowest output setting necessary to achieve the desired surgical effect. Use the active
electrode only for the minimum time necessary in order to lessen the possibility of unintended
burn injury. Pediatric applications and/or procedures performed on small anatomic structures may
require reduced power settings. The higher the current flow, and the longer the current is applied,
the greater the possibility of unintended thermal damage to tissue, especially during use on small
structures.
1. U.S. Department of Health and Human Services. National Institute for Occupational Safety
and Health (NIOSH). Control of Smoke from Laser / Electric Surgical Procedures. HAZARD
CONTROLS, Publication No. 96-128, September, 1996).
Notices:
If required by local codes, connect the generator to the hospital equalization connector with an
equipotential cable.
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the generator.
SYMBOLS DESCRIPTION
Cut Controls
Cut Mode
Blend Mode
Coag Controls
Pinpoint Mode
Spray Mode
Bipolar Controls
Bipolar Mode
Indicators
Regulatory Symbology
Cut Mode
Coag Mode
Bipolar Mode
Recall Button
Toggles through the 10 presets. Stop
at the desired number (0-9) illumi-
nated in the Preset Number Display
to recall a Preset.
Set Button
Sets the desired preset into one of
the 10 user-defined presets. Press Preset Indicator LED
and hold the Set button for three Blinks in the lower right corner of
seconds to save the settings. the Preset display to indicate that
the current setting is not one of the
user-defined presets.
NOTICES:
The ASG-300 incorporates 10 factory-set presets that are all set to zero and can be reset to your
preferred settings.
Set and Recall are disabled while the unit is activated.
NOTICE:
When selecting the Blend mode, the unit defaults to a setting of minimum blend (only the first bar
is illuminated).
Power Indicator
Illuminates when the
Split Return Solid Return Alarm Indicator
main power is on.
Electrode Indicator Electrode Indicator Illuminates when the system
Illuminates green Illuminates green detects a return electrode
when the system when the system alarm condition.
detects a split plate is detects a single plate.
properly placed on
the patient. Solid pad indicator
only detects that a pad
is connected to the
unit. The unit does not
monitor pad placement
on the patient.
SYMBOLS DESCRIPTION
Non-ionizing Radiation
Volume Control
Fuse Enclosed
Relay Connector
Manufacturer
● Initial Inspection
● Installation
● Function Checks
● Performance Checks
• Verify that the shipping package contains all items listed on the packing list.
If the unit or any accessories are damaged, notify DRE, Inc.’s Customer Service immediately.
Do not use any damaged equipment.
InstallatIon
Place the ASG-300 on any flat surface with a tilt angle not more than 10˚. The unit relies on natural convection cooling. Do not block
its bottom or rear vents. Ensure that air flows freely on all sides of the unit.
Warning:
Connect the power cord to a properly polarized and grounded power source with the frequency
and voltage characteristics that match those listed on the back of the unit.
FunctIon checks
Upon initial installation of the unit, perform the tests listed below. Refer to the figures in the previous chapter for the location of
connectors and controls.
Warning:
At no time should you touch the active electrode or bipolar forceps. A burn could result.
2. Connect a hospital grade power cable to the AC power cable receptacle on the back of the unit, then to a properly grounded
wall outlet.
3. Connect a two-button monopolar pencil to the appropriate receptacle. The use of Bovie pencils is recommended.
2. Press the Coag button of the pencil. Verify that an alarm sounds for three seconds and the patient return electrode sensing
alarm indicator light illuminates, indicating that no return electrode is connected to the unit.
3. Verify that adjusting the volume control on the back of the unit while the alarm is sounding does not change the alarm volume.
2. Press the pedal on the Bipolar footswitch. Verify that the Bipolar mode activation indicator illuminates and that the system
generates the Bipolar activation tone.
3. While activating the Bipolar mode, rotate the volume control over the full range to verify that the sound is audible throughout
the range.
4. Confirm that releasing the pedal returns the unit to an idle state.
2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator
illuminates.
3. Press the Cut pedal (yellow) on the footswitch. Verify that the Cut mode activation indicator illuminates and that the system
generates the Cut activation tone.
4. While activating the Cut mode, rotate the volume control over the full range to verify that the sound is audible throughout
the range.
5. Press the Coag pedal (blue) on the footswitch. Verify that the Coag mode activation indicator illuminates and that the system
generates the Coag activation tone.
6. While activating the Coag mode, rotate the volume control over the full range to verify that the sound is audible throughout
the range.
2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator
illuminates.
3. Activate, one at a time, the Cut and Coag handswitching controls. Verify that each control causes the correct indicator and tone to
sound.
peRFoRMance checks
After the unit has passed the preliminary functional test, it is ready for performance testing. A qualified biomedical engineer who
is thoroughly familiar with electrosurgical devices should conduct this testing. The testing should include checking all modes of
operation for proper function and power output.
● Setup Safety
● Setting Up
● Activation Safety
Cautions:
Read all warnings, cautions, and instructions provided with this generator before use.
Read the instructions, warnings, and cautions provided with electrosurgical accessories before
use. Specific instructions are not included in this manual.
• Inspect for damage to the Electrosurgical Generator and all its connections.
• Inspect all cords and connectors for signs of wear, damage, and abrasion.
setup safety
Warnings:
HazardousElectricaloutput - This equipment is for use only by trained, licensed physicians.
ElectricshockHazard - Connect the generator power cord to a properly grounded receptacle.
Do not use power plug adapters.
Connect the power cord to a properly polarized and grounded power source with the frequency
and voltage characteristics that match those listed on the back of the unit.
FireHazard - Do not use extension cords.
Patientsafety - Use the generator only if the self-test has been completed as described.
Otherwise, inaccurate power outputs may result.
The instrument receptacles on this generator are designed to accept only one instrument at a
time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing
so will cause simultaneous activation of the instruments.
Failure of the high frequency electrosurgical equipment could result in an unintended increase of
output power.
Do not use electrosurgical equipment unless properly trained to use it in the specific procedure
being undertaken. Use by physicians without such training has resulted in serious, unintended
patient injury, including bowel perforation and unintended, irreversible tissue necrosis.
For surgical procedures where the high frequency current could flow through parts of the body
having a relatively small cross-sectional area, the use of bipolar techniques may be desirable to
avoid unwanted coagulation.
If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for
instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple
activation of ICDs.
In some circumstances, potential exists for alternate site burns at points of skin contact (e.g.,
between the arm and the side of the body). This occurs when electrosurgical current seeks a path
to the patient return electrode that includes the skin-to-skin contact point. Current passing through
small skin-to-skin contact points is concentrated and may cause a burn. This is true for grounded,
ground referenced, and isolated output generators.
To reduce the potential for alternate site burns, do one or more of the following:
• Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient.
• Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does
not occur.
• Position the return electrode to provide a direct current route between the surgical site and
the return electrode which avoids skin-to-skin contact areas.
• In addition, place return electrodes according to the manufacturer’s instructions.
Potential for alternate site burns increases if the return electrode is compromised. DRE, Inc.
recommends the use of split return electrodes and generators with a contact quality
monitoring system.
notIce:
If required by local codes, connect the generator to the hospital equalization connector with an
equipotential cable.
settIng up
1. Verify that the generator is Off by pressing the power switch Off (O).
2. Place the generator on a stable flat surface, such as a table, platform, or medical cart. Carts with conductive wheels are
recommended. For details, refer to the procedures for your institution or to local codes. Provide at least 10 to 15 cm (4 to 6 in.)
of space from the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when you use the
generator continuously for extended periods of time.
3. Plug the generator power cord into the AC Power Cable Receptacle on the rear panel.
5. Turn on the generator by pressing the power switch On (|). Verify the following:
• Each display shows a power setting. The unit automatically powers up to the last selected preset settings.
If the self-test is not successful, an alarm tone sounds. An error code will appear in the Bipolar display, in most cases, the generator
is disabled. Note the error code and refer to Section 6, Troubleshooting.
Once the self-test is successful, connect the accessories and set the generator controls. Refer to Preparing for Monopolar Surgery or
Preparing for Bipolar Surgery later in this section.
notIces:
The Bovie NEM™ system recommends that you use a split return electrode.
Before activation, pad placement and visual verification of the split return electrode (split pad) indi-
cator on the front panel is recommended. After connecting the split pad to the generator and plac-
ing the split pad securely to the patient, give the unit 5 to 10 seconds to recognize the split pad.
The split pad indicator will illuminate green. If the split pad and cord are attached to the generator
without secure contact to the patient, the alarm indicator will illuminate red.
Refer to the manufacturer’s instructions for application site and placement procedures. When using metal plate return electrodes,
use a conductive gel specifically designed for electrosurgery. Select a return electrode site with good blood flow. While a properly
applied electrode results in minimal tissue heating beneath the electrode, a good blood flow helps carry heat away from the site.
1. Connect the cable to the Return Electrode receptacle on the front of the unit.
The unit will automatically sense the presence of a split or solid return electrode and, if a split return electrode is used,
will constantly monitor the resistance at the contact between the electrode and the patient.
2. Adjust the Blend setting to the desired amount of hemostasis (Level 1 - 10). Adjustment is preformed by pressing the up or down
buttons next to the Blend setting indicator.
Select the desired power settings for Cutting. Adjustment is preformed by pressing the up or down buttons next to the Cut display.
Select the desired power setting for Coagulation. Adjustment is preformed by pressing the up or down buttons next to the
Coag display.
ifyouareusing… Connectitto…
connecting accessories
1. Connect a 3-pin monopolar device into the monopolar receptacle on the front of the unit.
If footswitching control capabilities are preferred, connect the Bovie monopolar footswitch to the appropriate footswitch connecting
socket on the rear of the unit.
To activate the Monopolar mode, depress the cut or coag button on the monopolar handpiece or the cut or coag pedal on the
monopolar footswitch.
3. Connect the bipolar footswitch to the bipolar footswitch connecting socket located on the rear of the unit.
To activate the Bipolar mode, depress the pedal on the bipolar footswitch.
Memory
The Memory feature allows the ASG-300 (unit) to display the last selected Preset when the generator is turned on. When activated
by the handpiece or footswitch, the unit will operate in that particular mode and power setting.
The small red blinking dot in the lower right hand corner of the Preset display lets the user know that the Preset values have been
adjusted.
All new settings must be saved as a Preset to be available at startup or as a Preset selection (0 through 9) when using the unit.
• Mode (Cut and Coag) membrane switches are disabled during activation.
• During activation, the activated mode can be adjusted up and or down a maximum of four steps. Refer to the following table
for power increments.
• While operating the unit outside of a user-defined preset (small red dot will be blinking in lower right corner of the Preset
display as an indicator), the unit temporarily stores the power setting for the activated mode (Cut, Coag, or Bipolar).
This temporary power setting is available until either the unit is reset, a preset is selected , or the power setting for the mode in
use is adjusted and the unit is again activated.
• Presets only store one Cut mode (Cut I or Cut II, or Blend) and power setting, one Blend level (if applicable), one Coag mode
(Pinpoint or Spray) and power setting, and Bipolar power setting. When storing, only the information displayed in the display
windows will be saved to the unit’s memory.
Select the desired modes to be stored by pressing the mode membrane switches (Cut and Coag).
If presetting the Blend mode, select the desired level of hemostasis (Blend Bar 1-10) by pressing the
Blend amount control button.
Select the desired power (Cut, Coag, and Bipolar) to be stored by using the power output up and down membrane switches.
Once all of the settings are selected, depress and hold the Set button for three seconds. To indicate the settings have been
stored, the Preset Memory Number (0-9) will blink.
To recall a Preset, repeatedly press the Recall button to toggle through all of the presets.
notIces:
The ASG-300 incorporates 10 factory-set presets that are all set to zero and can be reset to your
preferred settings.
A small red dot blinking in the lower right corner of the Preset indicator display indicates that the
unit is not presently set to a user-defined preset.
Set and Recall buttons are disabled while the unit is activated.
Presets only store one Cut mode (Cut I or Cut II, or Blend) and power setting, one Blend level (if
applicable), one Coag mode (Pinpoint or Spray) and power setting, and Bipolar power setting.
When storing, only the information displayed in the display windows will be saved to the unit’s
memory.
notIce:
To have a setting selection available at startup or to be one of the 10 user-defined presets, the
adjustment to the mode and/or power settings must be saved by pressing the Set button on the
Preset display panel.
Examples
Examples 1 through 4 explain how the Memory and temporary memory features work and what happens when the power and/or
mode is adjusted but not saved as one of the 10 Preset selections. Example 5 explains what happens when the power and/or mode is
adjusted and saved as a new Preset setting:
#2. The physician performs a surgical procedure using Preset 2. The Preset has been stored with the following mode and power:
#3. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values).
He adjusts the power settings for each mode but does not store the new settings into the Preset.
The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The
number 2 Preset will be the same as the modes and settings indicated in Example #1.
#5. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values.).
As required in the procedure, he selects the Blend mode (the Blend Amount Indicator illuminates to one bar indicating the Blend
mode can be increased to the preferred amount of blend). He adjusts the hemostasis level up to a 30% blend but does not store
the new settings into the Preset. The next time the unit is switched on, the number 2 Preset will be displayed and available when
the unit is activated. The number 2 Preset will be the same as the modes and settings indicated in Example #1.
#6. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values). He adjusts the power settings
for a Cut mode, a Coag mode, and a Bipolar mode and presses the Store button for three seconds to save the new settings as
Preset number 2. The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is
activated. The number 2 Preset will now be the last saved Preset settings for Preset 2.
1. Monopolar Cut - select the mode of operation for Cut: Cut I, Cut II, or Blend then select the desired Cut power settings by pressing
the up and down buttons next to the Cut power output display.
2. If using Blend, vary the Blend setting by pressing the up and down buttons next to the blend amount indicator graph.
3. Monopolar Coag - select the mode of operation for coagulation: Pinpoint or Spray, then select the coagulation power settings by
pressing the up and down buttons next to the Coag power output display.
4. Bipolar - adjust the Bipolar power settings by pressing the up and down buttons next to the Bipolar power output display.
5. Activate the generator by pressing the appropriate button on the handpiece or pedal on the footswitch.
notIce:
Monopolar and bipolar footswitching operations are controlled by independent foot controls.
Cautions:
The use of high frequency current can interfere with the function of other electromagnetic
equipment.
When high frequency surgical equipment and physiological monitoring equipment are used
simultaneously on the same patient, place any monitoring electrodes as far as possible from
the surgical electrodes.
Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent
electrosurgical burns may result.
To avoid the possibility of an electrosurgical burn to either the patient or the physicians, do not
allow the patient to come in contact with a grounded metal object during activation. When
activating the unit, do not allow direct skin contact between the patient and the physician.
To avoid the possibility of a burn to the patient, when using a split pad do not activate the unit if
the solid pad indicator is illuminated green or the red alarm indicator remains illuminated red. This
could indicate improper pad placement or a faulty NEM circuit.
Remove any jewelry from the patient before activation.
Studies have shown that smoke generated during electrosurgical procedures can be potentially
harmful to patients and the surgical team. These studies recommend adequately ventilating the
smoke by using a surgical smoke evacuator or other means.1
Examine all accessories and connections to the electrosurgical generator before use. Ensure that
the accessories function as intended. Improper connection may result in arcs, sparks, accessory
malfunction, or unintended surgical effects.
● Cleaning
● Periodic Inspection
● Fuse Replacement
CLEANING
After each use, clean the unit.
WARNING:
Electric Shock Hazard - Always turn off and unplug the generator before cleaning.
NOTICE:
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the generator.
1. Turn off the generator, and unplug the power cord from the wall outlet.
2. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth.
Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the
chassis. Do not sterilize the generator.
PERIODIC INSPECTION
Every six months, visually inspect the ASG-300 for signs of wear or damage.
In particular, look for any of the following problems:
FUSE REPLACEMENT
Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit.
Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the errors,
and recommends actions to take to resolve the errors.
Notice:
If the unit does not power on to display an error, check fuses as described in Section 5 of
this guide.
• The user has followed the Installation and Setup Procedures in this User’s manual.
• Persons authorized by DRE, Inc. performed assembly operation, readjustments, modifications,
or repairs.
• The electrical installation of the relevant room complies with local codes and regulatory requirements, such as
IEC and BSI.
• Equipment use is in accordance with the DRE, Inc. instructions for use.
Please note that infected medical devices must be disposed of as medical/biohazard waste and cannot be included in used
electronic equipment disposal/recycling programs. In addition, certain electronic products must be returned directly to distributor.
Contact your DRE, Inc. representative for return instructions.
NOTICE:
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the generator.
A. Turn off the generator, and unplug the power cord from the wall outlet.
B. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth.
Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the
chassis. You cannot sterilize the generator.
B. Be sure the generator is completely dry before you pack it for shipment. Package it in its original shipping container, if available.
Please be sure to include a reference to the RMA Number on the outside of the box/container.
C. Ship the generator, prepaid, to the address given to you by the DRE representative.
Duty Cycle
Under maximum power settings and rated load conditions (Pure Cut, 300 watt @ 300 ohm load), the generator is suitable for
activation times of 10 seconds ON followed by 30 seconds OFF for one hour.
The internal temperature of the unit is continuously monitored. If the temperature rises above 850 C, the alarm will sound and
output power will be deactivated.
Operating Parameters
Ambient temperature range 10° to 40° C
Relative humidity 30% to 75%, non-condensing
Atmospheric pressure 70kPa to 106kPa
If transported or stored at temperatures outside the operating temperature range,
Warm-up time
allow one hour for the generator to reach room temperature before use.
Activation Tone
Volume (adjustable) 40 to 65 dB
Frequency Cut I: 610 Hz
Cut II: 610 Hz
Blend: 610 Hz
Pinpoint: 910 Hz
Spray: 910 Hz
Bipolar: 910 Hz
Duration Continuous while the generator is activated
Alarm Tone
Volume (not adjustable) 70 dB ± 5 dB
Frequency 2 kHz 1⁄2 seconds / 1 kHz 1⁄2 seconds
Duration 2 seconds
Electromagnetic Interference
When other equipment is placed on or beneath a ASG-300, the unit can be activated without interference.
The generator minimizes electromagnetic interference to video equipment used in the operating room.
EMC COMPLIANCE
Special precautions should be taken regarding the ASG-300. Medical Electrical Equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC information provided in this manual.
Understand that only the Accessories supplied with or ordered from DRE Medical should be used with your device. The use of
accessories, transducers, and cables other than those specified, may result in increased Emissions or decreased Immunity of the
ASG-300. The ASG-300 and its accessories are not suitable for interconnection with other equipment.
Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The ASG-300 should not be used
adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the ASG-300 should be observed to
verify normal operation in the configuration in which it will be used.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
The ASG-300 is intended for use in the electromagnetic environment listed below. The customer or
the user of the ASG-300 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
<5 % Ut <5 % Ut
(<95 % dip in Ut) (<95 % dip in Ut)
for 0.5 cycle for 0.5 cycle Mains power quality should be
that of a typical commercial or
<40 % Ut <40 % Ut
Voltage dips, short (<60 % dip in Ut) (<60 % dip in Ut) hospital environment. If the user
interruptions and voltage for 5 cycles of the ASG-300 requires contin-
for 5 cycles
variations on power sup- ued operation during power mains
ply input lines 70 % Ut 70 % Ut interruptions, it is recommended
(<30 % dip in Ut) (<30 % dip in Ut)
IEC 61000-4-11 that the ASG-300 be powered
for 25 cycles for 25 cycles
from an uninterruptible power
<5 % Ut <5 % Ut supply or a battery.
(>95 % dip in Ut) (>95 % dip in Ut)
for 5 sec for 5 sec
Power frequency magnetic fields
Power frequency (50/60 should be at levels characteristic
Hz) magnetic field 3 A/m 3 A/m of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE Ut is the a.c. mains voltage prior to application of the test level.
d = [7 ]√ P
E1
800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to the
3 V/m transmitter manufacturer and d is the
Radiated RF
80 MHz to 3 V/m recommended separation distance in metres
IEC 61000-4-3 (m)
2.5 GHz
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location which the ASG-300 is used exceeds the applicable RF compliance level above, the ASG-300
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the ASG-300.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
DRE, Inc. obligation under this warranty is limited to the repair or replacement, at its sole option, of any
product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown
below after delivery of the product to the original purchaser, and which examination discloses, to DRE, Inc.’s
satisfaction, that the product is indeed, defective.
This warranty does not apply to any product, or part thereof, which has been repaired or altered outside DRE, Inc.’s
facility in a way so as, in DRE, Inc.’s judgment, to affect its stability or reliability, or which has been
subjected to misuse, neglect, or accident.
• Electrosurgical Generators: Two years after delivery of the product to the original purchaser
• Mounting Fixtures (all models): Two years after delivery of the product to the original purchaser
• Footswitches (all models): Ninety days after delivery of the product to the original purchaser
DRE, Inc. neither assumes nor authorizes any other person to assume for it any other liability in connection with the
sale or use of any of DRE, Inc.’s products.
Notwithstanding any other provision herein or in any other document or communication, DRE, Inc.’s liability with
respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods
sold by DRE, Inc. to the customer.
DRE, Inc. disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or
consequential damages.
This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the
State of Florida, USA.
The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the
County of Pinellas, State of Florida, USA.
DRE, Inc., its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them
at any time without incurring any obligation to make the same or similar changes on equipment previously built
and/or sold by them.