surgmaster_ues-40_electrosurgical_unit_instructions.pdf
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INSTRUCTIONS
ELECTROSURGICAL UNIT
UES-40
Page 3
Important Precautions Critical for Safety (Be sure to read this information before use.)
Important Precautions Critical for Safety
(Be sure to read this information before
use.)
•
Before performing electrosurgical therapy, thoroughly study the
properties, purposes, effects and possible risks (the nature, extent and
probability) of the planned treatment and any alternative therapeutic
method that can be performed. Perform therapy only when its benefits
outweigh its risks. During endoscopic treatment, continue to evaluate
the potential benefits and risks, and stop the treatment if the risks
become greater than the possible benefit to the patient.
•
The flow or discharge of high-frequency current could injure the patient,
operator and/or assistant. When handling this product, also pay close
attention to all “DANGER”, “WARNING” and “CAUTION” statements
given in this manual.
•
Make sufficient preparations for treatment of unexpected emergencies
such as burns, bleeding and puncturing before using this product.
ELECTROSURGICAL UNIT UES-40
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Important Precautions Critical for Safety (Be sure to read this information before use.)
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ELECTROSURGICAL UNIT UES-40
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Contents
Contents
Important Precautions Critical for Safety (Be sure to read this
information before use.)...............................................................
i
Labels and Symbols .....................................................................
1
Important Information — Please Read Before Use....................
3
Intended use ............................................................................................
3
Instruction manual ....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility ...........................................................................
4
Repair and modification ...........................................................................
4
Signal words .............................................................................................
4
Dangers, warnings and cautions ..............................................................
5
Chapter 1
Checking the Package Contents............................
12
Chapter 2
Nomenclature and Functions .................................
14
2.1
Symbols and descriptions ...............................................................
14
2.2
Front panel......................................................................................
17
2.3
Rear panel ......................................................................................
21
2.4
Foot switch for UES-40 (MAJ-1258) ...............................................
23
2.5
Bipolar foot switch for UES-40 (MAJ-1259) ....................................
24
2.6
A adapter 2 (MAJ-619)....................................................................
25
2.7
A adapter 3 (MAJ-620)....................................................................
25
Installation and Connection ...................................
26
3.1
Installation of equipment .................................................................
26
3.2
Connection to an AC mains power supply ......................................
27
3.3
Connection of foot switch MAJ-1258 ..............................................
28
3.4
Connection of foot switch MAJ-1259 ..............................................
29
3.5
Connection of the patient plate (for monopolar treatment) .............
30
3.6
Connection of the hand piece (for monopolar treatment) ...............
34
3.7
Connection of the A cord (for monopolar treatment).......................
35
3.8
Connection of the A adapter 2 (MAJ-619) ......................................
36
3.9
Connection of the A adapter 3 (MAJ-620) ......................................
37
Chapter 3
3.10 Connection of the bipolar electrode and bipolar cord (for bipolar treatment)
38
3.11 Connection of the saline electrode and saline cord (for saline treatment)
ELECTROSURGICAL UNIT UES-40
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Contents
40
Chapter 4
Inspection.................................................................
41
4.1
Inspecting the connections .............................................................
41
4.2
Inspection of the UES-40 ................................................................
42
4.3
Inspection of the foot switch operation............................................
43
4.4
Bipolar setting .................................................................................
44
4.5
Monopolar setting ...........................................................................
45
4.6
Saline setting (when saline output mode is used)...........................
46
4.7
Inspection of warning function ........................................................
49
Operation..................................................................
51
5.1
Turn the power ON .........................................................................
52
5.2
Automatic memory mode ................................................................
52
5.3
Preset mode....................................................................................
53
5.4
Selection of saline mode .................................................................
56
5.5
Selection of foot switch output ........................................................
57
5.6
Selection of cut mode .....................................................................
58
5.7
Selection of coagulation mode ........................................................
60
5.8
Setting output ..................................................................................
63
5.9
Maximum output .............................................................................
64
5.10 Electrosurgery .................................................................................
65
5.11 Automatic exhaust ..........................................................................
67
5.12 Procedure after use ........................................................................
68
Chapter 5
Chapter 6
Care, Storage and Disposal ....................................
70
6.1
Care ................................................................................................
70
6.2
Storage ...........................................................................................
71
6.3
Care of A adapter 2 and A adapter 3 ..............................................
71
6.4
Storage of A adapter 2 and A adapter 3 .........................................
72
6.5
Disposal ..........................................................................................
72
Troubleshooting ......................................................
73
7.1
Troubleshooting guide ....................................................................
73
7.2
Alarm functions ...............................................................................
80
7.3
Returning the UES-40 for repair......................................................
84
Appendix........................................................................................
85
Construction .............................................................................................
85
Output mode chart ....................................................................................
87
System chart .............................................................................................
88
Chapter 7
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ELECTROSURGICAL UNIT UES-40
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Contents
Operating and storage environments........................................................
92
Specifications ............................................................................................
93
EMC information .......................................................................................
106
ELECTROSURGICAL UNIT UES-40
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Contents
vi
ELECTROSURGICAL UNIT UES-40
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are attached to the instrument at the location
shown below.
If labels or symbols are missing or illegible, contact Olympus.
Rear side
Serial number
Electrical rating plate
Product name and rated voltage
are displayed.
Crossed-out wheeled bin’ symbol
ELECTROSURGICAL UNIT UES-40
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Labels and Symbols
Electrical rating plate
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
2
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This instrument has been designed for use in a medical facility under the
supervision of a trained physician. It has been designed for general (open) and
endoscopic surgery including urology, gynecology, respiratory and
gastroenterology in conjunction with Olympus designed electrosurgical
accessories, endoscopes (fiberscopes, videoscopes and rigid scopes)
applicable for electrosurgery (cutting and coagulation), light sources and other
ancillary equipment.
Do not use this instrument for any purpose other than its intended use.
Instruction manual
This instruction manual contains essential information on using this instrument
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment which will be used during the procedure and use the
equipment as instructed.
Keep this and all related instruction manuals in a safe, accessible location.
If you have any questions or comments about any information in this manual,
please contact Olympus.
Terms used in this manual
Wall mains outlet
An electrical outlet that has a terminal used exclusively for grounding.
User qualifications
The operator of this instrument must be a physician or medical personnel under
the supervision of a physician and must have received sufficient training in
electrosurgical procedures. This manual, therefore, does not explain or discuss
endoscopic or electrosurgical procedures.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used.
Using incompatible equipment can result in patient injury and/or equipment
damage.
This instrument complies with the EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an
instrument that complies with the EMC standard for medical electrical
equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with
edition 1.
Repair and modification
This instrument does not contain any user-serviceable parts. Do not
disassemble, modify, or attempt to repair it; patient or user injury and/or
equipment damage can result.
Some problems that appear to be malfunctions may be correctable by referring
to Chapter 7, “Troubleshooting”.
If the problem cannot be resolved using the information in Chapter 7, contact
Olympus.
Signal words
The following signal words are used throughout this manual:
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. It may also
be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.
4
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
Dangers, warnings and cautions
Follow the dangers, warning and cautions given below when handling this
instrument. This information is to be supplemented by the dangers, warnings
and cautions given in each chapter.
•
The high-frequency (HF) equipment, when applied to a
patient with a pacemaker implanted, may cause malfunction
or failure of the pacemaker, seriously affecting the patient.
Before proceeding, confirm with a cardiologist and the
manufacturer of the pacemaker that it is safe to do so.
•
To prevent shock hazards, never apply the UES-40 to the
heart in combination with type B or type BF applied part.
•
When using the UES-40 on or in the vicinity of the heart, be
sure to use it with the minimum necessary output. Spark
discharge during operation may affect the heart.
•
The UES-40 is not explosion-proof construction. Never install
or operate it where flammable gases are present.
•
Never install or operate the UES-40 where:
the concentration of oxygen is high.
oxidizing agents (such as nitrous oxide [N2O]) are present
in the atmosphere.
flammable anesthetics and/or gases are present in the
atmosphere.
•
If absorbent cotton or gauze is used during the procedure, it
can be ignited by a spark generated in the normal operation
of the equipment.
•
Prepare a spare UES-40 as a backup to ensure that the
procedure can be completed without complication in case of
a malfunction. If therapy is possible using non-electrosurgical
equipment, it is also acceptable to prepare such equipment
as a backup.
•
Always have a defibrillator ready in case of a cardiac
emergency. During operation of the defibrillator, remove the
endoscope from the patient.
•
Never attach the patient plate in the vicinity of a metal
implant. The tissue in the vicinity of the metal implant may be
burned.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
6
•
Be sure that this instrument is not used adjacent to or
stacked with other equipment (other than the components of
this instrument or system) to avoid electromagnetic
interference.
•
Electromagnetic may occur to this instrument near
equipment marked with the following symbol or other
portable and mobile RF communications equipment such as
cellular phones. If radio interference occurs, mitigation
measures may be necessary, such as reorienting or
relocating this instrument or shielding the location.
•
Keep the UES-40 and ancillary cords (A cord, bipolar cord,
patient plate cord, hand piece cord) as far away as possible
from other electromedical equipment and cords. If placed too
close, high-frequency signals or spark discharge noise from
the UES-40 may interfere with the operation of other
equipment.
•
To prevent patient burns, the UES-40 and ancillary cords (A
cord, bipolar cord, patient plate cord, hand piece cord) should
not come in contact with the patient or metal parts of the
operating table. Furthermore, the patient should also be kept
away from metallic parts of the operating table or other
devices.
•
Never loop the cords (A cord, bipolar cord, patient plate cord,
hand piece cord) or bundle cords together with cords
belonging to other medical equipment. The high-frequency
signals or spark discharge noise generated by the UES-40
may interfere with the operation of other medical equipment.
•
Do not apply excessive bending, straining, or squeezing
force to any cords. It may cause malfunction.
•
Always use the UES-40 as outlined in this instruction manual.
Improper use will not only impede functions and prevent
optimum performance, but may cause equipment damage
and/or complications. Before each use, always inspect the
equipment as outlined in this instruction manual.
•
The UES-40 may interfere with electromedical equipment
used in conjunction with it. Before use, thoroughly confirm
the compatibility of all equipment.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
•
To prevent the risk of electric shock, the housing of the
UES-40 must be grounded. Always connect the power cord
plug to a properly grounded hospital grade AC receptacle
(wall mains outlet) as shown in the figure below. Do not use a
3-pin/2-pin adapter, as it can impair safe operation of the unit.
Hospital grade
AC receptacle
•
To prevent electric shock, the UES-40 is designed to function
with insulated connectors that have Type CF electromedical
equipment classifications (A cord, hand piece, patient plate).
Therefore, to prevent shock caused by leakage current from
other electrical equipment applied to the patient, the
connectors should not be grounded.
•
Should any abnormal output be suspected during operation,
immediately terminate the use of the equipment and turn
OFF the power switch. Otherwise, malfunction of the
equipment may cause an unintended increase in output.
•
To prevent operator shock and instrument damage, keep
liquids away from all electrical equipment. If liquid gets on or
into the UES-40, terminate operation immediately and
contact Olympus.
•
To prevent patient burns, the patient’s skin surfaces should
not touch each other (e.g. bare arm and side of chest).
•
To prevent patient burns, the operator and assistant should
wear protective gloves during the procedure.
•
To prevent patient burns during fiberscopic or videoscopic
treatment, the patient’s clothes must be dry.
•
If the intestines contain a flammable gas, replace it with air or
a non-flammable gas before performing the operation, to
minimize the risk of fire or explosion.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
•
During fiberscopic or videoscopic treatment, be sure that the
distal end of the endoscope and metallic parts of the
accessory do not touch the normal tissue surrounding the
target tissue as this may cause severe burns.
•
During fiberscopic or videoscopic treatment, be sure that the
distal end of the endoscope or accessory does not contact
bridging fluids surrounding the target tissue. Electric current
may flow to the surrounding normal tissue via the fluids and
cause burns.
•
During fiberscopic or videoscopic treatment, never grasp the
target tissue with non-insulated grasping forceps.
Non-insulated grasping forceps will disperse the electric
current and normal operation may be impeded.
•
To ensure electrical safety, the UES-40 should not be used in
conjunction with:
Electrical equipment whose safety against leakage
current is not guaranteed.
Electrosurgical equipment whose safety in combined use
is not guaranteed.
8
•
The UES-40 should only be used under the conditions
described in , “Operating environment” in the Appendix. Use
under other conditions may impede normal performance
and/or result in equipment damage.
•
If the UES-40 is used in conjunction with a non-Olympus
electrosurgical unit, keep the electrosurgical accessory away
from the target area while the UES-40 is in operation. Do not
activate output of both units simultaneously. Patient or
operator injury may occur due to the concentration of electric
current.
•
When using an electrocardiograph or other physiological
monitoring equipment simultaneously with the UES-40 on a
patient, any monitoring electrodes should be placed as far
away as possible from the electrodes (accessories/hand
piece and patient plate) used with the UES-40. If placed too
close, high-frequency signals or spark discharge noise from
the UES-40 may interfere with the operation of an
electrocardiograph or other physiological monitoring
equipment. Needle monitoring electrodes should not be
used, as they may cause patient burns. Physiological
monitoring equipment incorporating high-frequency current
limiting devices is recommended.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
•
The maximum output voltage characteristics of the UES-40
are shown below. When setting the output level, first set it to
a low level and increase it gradually. If the output is initially
set to a high level, the electrode’s insulation may be
damaged and cause operator and/or patient burns.
Furthermore, it is recommended that you perform basic
experiments before using the UES-40. If the instruction
manual for the endoscopic accessory to be used stipulates a
rated voltage, the output should be set so that it does not
exceed that voltage.
MAXIMUM
OUTPUT VOLTAGE (V)
Monopolar
(1) PURE, URO
(2) BLEND
(3) COAG1
(4) COAG2
(5) SPRAY
POWER SETTING (W)
MAXIMUM
OUTPUT VOLTAGE (V)
Bipolar
(1) PURE
(2) SOFT1, SOFT2
POWER SETTING (W)
MAXIMUM
OUTPUT VOLTAGE (V)
Bipolar
(3) HARD
SETTING
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
MAXIMUM
OUTPUT VOLTAGE (V)
Saline
(1) PURE
(2) BLEND
(3) COAG1
(4) COAG2
POWER SETTING (W)
10
•
Flammable agents used for cleaning and disinfection must be
allowed to evaporate before the UES-40 is used. Also ensure
that flammable solutions are neither on the patient’s skin nor
in the patient’s body cavity when the UES-40 is used.
•
For surgical procedures where the high-frequency current
could flow through parts of the body with a relatively small
cross-sectional area, use of the bipolar mode may be
desirable to avoid accidental coagulation.
•
To prevent patient burns when the UES-40 is used in
conjunction with a non-Olympus electrosurgical unit, ensure
that each unit is supplied with power from separate
electrosurgical units. Also ensure that each unit is supplied
with power from separate breakers.
•
During operation, temporarily unused electrodes should be
stored in an electrically insulated container. Unused
electrodes should never be placed on the patient. Otherwise,
it may cause patient and/or operator burns.
•
Studies have shown that smoke generated during
electrosurgical procedures can be irritating and potentially
harmful to surgical personnel. These studies recommend the
use of surgical masks and adequate ventilation of smoke
using surgical smoke evacuators or other means.
ELECTROSURGICAL UNIT UES-40
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Important Information — Please Read Before Use
William S. Sawchuk, et al., “Infectious Papillomavirus in
the Vapor of Warts Treated With Laser or
Electrocoagulation: Detection and Protection”, Journal of
American Academy of Dermatology, Vol.21, No.1 (July,
1989): 41 – 49.
Yoshifumi Tomita, et al., “Mutagencity of Smoke
Condensates Induced by CO2-Laser Irradiation and
Electrocauterization”, Mutation Research, Vol.89 (1989):
145 – 149.
Evaluation Report No.85 – 126. (National Technical
Information Service, 1985): 1 – 28.
•
When the patient is moved after the dispersive electrode has
been attached, confirm that the dispersive electrode is still in
proper contact with the patient. Otherwise, it may cause
patient and/or operator burns.
•
This instrument cannot be used with an endoscope equipped
with the S cord connector receptacle.
•
If the UES-40 is used with a rigid endoscope and is providing
monopolar output, activation of the UES-40 when not in
contact with target tissue or in a position to deliver energy to
target tissue (fulguration) may cause capacitive coupling.
•
Do not use the UES-40 in a location exposed to strong
electromagnetic radiation (microwave or short-wave medical
treatment equipment, MRI, radio or mobile phone
equipment). These can impair operation of the unit.
•
Always confirm that the unit is safe to use in the system
configuration that you have arranged. In general, the unit
should be used only with equipment shown in the “System
chart” in the Appendix. Using the unit in a configuration that
includes equipment not shown in the “System chart” may not
only prevent the unit from performing as intended, it can
cause patient or operator injury and/or equipment damage.
When you intend to use the unit in a configuration that
includes equipment other than that shown in the “System
chart”, confirm that the unit functions safely in that system
configuration before proceeding.
•
Never bring the electrocautery tip in contact with a metallic
clip, electrosurgical accessory or retractor. Doing so could
cause burns to tissue in the vicinity.
•
To prevent instrument damage, never short-circuit electrodes
(accessories, hand piece or patient plate).
•
Repairs should be performed only by Olympus.
ELECTROSURGICAL UNIT UES-40
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
Match all items in the package with the components shown below. Inspect each
item for damage. If the instrument is damaged, a component is missing or you
have any questions, do not use the instrument; immediately contact Olympus.
Power cord
Electrosurgical unit (UES-40)
Instruction manual
Foot switch for UES-40 (MAJ-1258)
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ELECTROSURGICAL UNIT UES-40
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Chapter 1 Checking the Package Contents
The following Olympus items are optional items which may be purchased
separately:
•
A cord (A00012A, A00506A, A02915A (MAJ-860), A0335.1, A0336.1,
A0358, A0393)
•
Bipolar electrode (A5380, A5382, A5384, A5386, A5388, A5390, A5392,
A5394, O5119)
•
Bipolar cord (A00500A, A00504A, A5121.1, A5376, A5377)
•
A adapter 2 (MAJ-619)
•
A adapter 3 (MAJ-620)
•
P cord (MAJ-814)
•
Bipolar foot switch for UES-40 (MAJ-1259)
•
Interactive cable (MAJ-877)
•
Saline cord (WA00013A)
•
Patient plate (MAJ-897)
The following recommended non-Olympus items may also be purchased
separately:
•
Hand piece (for connection method, refer to Section 3.6, “Connection of
the hand piece (for monopolar treatment)”)
•
The patient plate (for compatible patient plates, refer to Section 3.5,
“Connection of the patient plate (for monopolar treatment)”)
•
The bipolar electrode (for compatible bipolar electrodes, refer to Section
3.10, “Connection of the bipolar electrode and bipolar cord (for bipolar
treatment)”)
•
Bipolar cord (for compatible bipolar cords, refer to Section 3.10,
“Connection of the bipolar electrode and bipolar cord (for bipolar
treatment)”)
For other equipment combinations, refer to the “System chart” in the Appendix.
•
Place the instruction manual next to the UES-40 or in another
easily accessible place.
•
Before using an optional item, thoroughly review and
understand the instruction manual provided with that item.
•
Some products may not be available in some regions. Please
contact the nearest Olympus office for details.
•
Specifications, design and accessories are subject to change
without any notice or obligation on the part of the
manufacturer.
ELECTROSURGICAL UNIT UES-40
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Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
2.1
Symbols and descriptions
Warning section
Caution, refer to instructions.
Output mode section
Bipolar
Monopolar
Saline
Power switch
Power ON/OFF
Front panel
Type CF equipment (defibrillation protected equipment)
Memory
Select for preset/Foot switch select
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ELECTROSURGICAL UNIT UES-40
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Chapter 2 Nomenclature and Functions
Connector section
Bipolar
Hand piece
Saline
Patient plate
Connection for neutral electrode (isolated from earth at
high-frequency)
Bipolar section
Soft1
Soft2
Hard
Monopolar section
Pure
Uro
ELECTROSURGICAL UNIT UES-40
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Chapter 2 Nomenclature and Functions
Blend
Coag.1
Coag.2
Spray
Saline section
Saline
Rear panel
Circuit breakers
Potential equalization terminal
Volume.
Foot switch
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ELECTROSURGICAL UNIT UES-40
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Chapter 2 Nomenclature and Functions
2.2
Front panel
11. Monopolar/saline cut
mode select switch
16. Memory switch
10. Monopolar/saline coagulation
mode select switch
15. Select switch
14. Bipolar coagulation mode select switch
9. Output control switches
13. Saline switch
12. Foot switch select switch
3. Bipolar
connector 2
8. Patient plate
connector
2. Bipolar
connector 1
7. Hand piece
connector 2
6. Hand piece connector 1
1. Power switch
5. Active connector
4. Saline connector
ELECTROSURGICAL UNIT UES-40
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Chapter 2 Nomenclature and Functions
27. Bipolar cut output setting indicator
28. Output indicators
26. Bipolar coagulation output setting indicator
25. Foot switch setting indicators
24. Monopolar/saline cut
output setting indicator
30. CQM indicator
23. Monopolar/saline coagulation
output setting indicator
29. Warning indicator
20. Saline mode indicator
22. Monopolar/saline
coagulation mode indicators
19. Bipolar coagulation mode indicators
18. Preset number indicator
17. Power switch indicator
18
ELECTROSURGICAL UNIT UES-40
21. Monopolar/saline cut
mode indicators