Utah Medical Products FINESSE + User manual

Service Manual
Electrosurgical Generator and
Smoke Evacuation System
Utah Medical Products, Inc.
7043 South 300 West • Midvale, Utah USA
www.utahmed.com
®

Copyright © 2018 by Utah Medical Products, Inc.
FINESSE®, UtahLoop®, UtahBall®, Safe-T-Gauge®, LETZ®, Epitome® and DXTender® are registered
trademarks, and Finesse+™, OptiMicro™ and ZapGuard™ are trademarks, of Utah Medical Products,
Inc., Midvale, Utah.
This manual may not be reproduced, in full or in part, without express written consent of Utah
Medical Products, Inc.
The information contained in the manual was correct when printed. Changes may occur that ren-
der portions of this manual inaccurate. Please contact Utah Medical Products, Inc. for updated
information if errors or changes in the contents of this manual are suspected.

Table of Contents
Introduction 1
Description and Application 1
Electrosurgical Generator 1
Smoke Evacuation System 2
Electrosurgical Procedure Guidelines 2
Operational Safety Notes and Warnings 4
Principles of Electrosurgery 9
Cutting 9
Coagulation 9
Complications 10
Smoke Evacuation and Filtration 10
Installation 11
Initial Setup 11
Functional Check 11
Maintenance 12
Device Description 15
Front Panel Indicators and Connectors 15
Rear Panel Controls and Connectors 19
Technical Data 21
Physical Specifications 21
Supply Voltage and Current Considerations 21
Output Characteristics 22
Smoke Evacuator System 25
Environmental Specifications 26
Circuit Descriptions 27
Test Procedures 31
Symbology 35
List of Drawings 37
Warranty and Service 47

List of Figures and Tables
Figure 1. FINESSE+ front panel, smoke evacuation module 15
Figure 2. FINESSE+ cut, coag, and error indicator functions 17
Figure 3. FINESSE+ front panel connections 18
Figure 4. FINESSE+ rear panel connectors and controls 19
Table 1. Output Characteristics 22
Figure 5. Typical output power vs. load resistance for cut and blend modes 23
Figure 6. Typical output power vs. load resistance for coag mode 23
Figure 7. Maximum Output Voltage vs. displayed settings 23
Figure 8. Typical output power vs. display settings 24
Table 2. Symbols used in conjunction with the FINESSE+ System 35

FINESSE+ Service Manual 1
Introduction
This manual is intended to:
• introduce you to the FINESSE+™ Electrosurgical Generator and Smoke Evacuation System,
• acquaint you with the principles of electrosurgery,
• make you aware of some important concerns inherent in electrosurgery, and provide instruc-
tions for operating this instrument in performing electrosurgical procedures.
Description and Application
The FINESSE+ system combines a high-quality, class I type BF electrosurgical generator and a
smoke evacuation system into a single compact unit. This integrated system was designed to per-
form low-power excision and coagulation procedures of short duration. It is not intended for
high-power procedures such as prostatic resection or for sustained operating room procedures
that require continual application of electrosurgical energy with only brief periods of rest.
Electrosurgical Generator
The electrosurgical generator module in the FINESSE+ system is designed according to the same
principles as the more powerful general surgery units that are commonly used in hospital operat-
ing rooms; however, its power output is limited to the range necessary for the shallower and less
extensive cuts that are performed in office-based electrosurgical procedures.
The output waveforms and load characteristics in the pure cut and blended cut modes are opti-
mized for excisions in which the cut starts with only a small area of the cutting electrode in con-
tact with tissue and proceeds to a maximum depth where the cutting line may be more than two
centimeters long. The Controlled Output Circuitry of the FINESSE+ system is a negative-feedback
output monitoring system that senses the changes in load resistance that occur throughout the
excision and adjusts the power to match the needs of the cut. This prevents excessive tissue dam-
age at the start and end of the cut and prevents slowing of the electrode when excising at the
maximum depth.
The FINESSE+ system provides a pure cut mode and three blend modes that perform concurrent
cutting and superficial coagulation as required by standard practice for excision procedures. The
coagulation mode provides sufficient voltage and power for spray coagulation, or fulguration,
using ball electrodes.
The generator incorporates an error detection and alerting system that will alert the user and shut
down output power whenever the following occurs:
1. both cut and coag modes are simultaneously keyed ("cross-key" error),
2. a dispersive pad cable breaks or becomes disconnected

2FINESSE+ Service Manual
3. a split-type dispersive pad partially separates from the patient (CQM, or contact quality moni-
toring), or
4. the actual output power exceeds the set output by an unsafe margin.
Smoke Evacuation System
The smoke evacuation system is integrated with the electrosurgical generator to enhance the con-
venience and safety of electrosurgical procedures, such as Loop Excision of the Transformation
Zone (LETZ®). Its purposes are to remove the smoke that would otherwise obscure the visual field
during the procedure, to filter particles from the smoke, and to adsorb the unpleasant odor.
The smoke evacuation system consists of four major components:
1. a first-stage HEPA particulate filter
2. a second-stage activated charcoal filter
3. a third-stage ULPA particulate filter
4. a vacuum motor that creates the negative pressure and the resulting airflow necessary to pull
the smoke from the surgical field and through the filters.
The first two filter stages are supplied as a disposable unit (FINESSE Filter Pack, catalog no. ESU-
501) that may be easily changed and discarded. The third-stage ULPA filter and vacuum system
are installed inside the FINESSE+ system housing. The ULPA filter (FINESSE+ Internal Filter, cata-
log no. SSE-500) is removable for annual replacement.
Electrosurgical Procedure Guidelines
The surgical techniques using low-power generators are described in several medical journal
papers and are being taught in current medical seminars. You are encouraged to learn the surgi-
cal methods from the established experts, then to read this manual carefully before using the
FINESSE+ system and instruments to perform these procedures. A bibliography of papers on the
subject is found later in this manual. Standard practice of these techniques may change as new
findings are published.
Because of the simplicity and low complication rate of electrosurgical excision procedures, some
practitioners have elected to perform these procedures in their offices. The decision whether or
not to follow this trend is the responsibility of the clinician. If the decision is made to perform
the procedure in the office, the clinician should be aware that no surgical procedure is performed
without risk and an appropriate degree of expertise must be developed to minimize these risks.
It should also be noted that office procedures should be limited to those that do not carry signifi-
cant risk of complications that may require emergency support. This criterion is met only when
the excisions are not too deep and when they are performed using the same techniques that have
been previously successful in the office environment.
The developers and providers of the FINESSE+ system will not presume to prescribe surgical tech-
niques in this manual. However, there are some guidelines and warnings that may be useful in

FINESSE+ Service Manual 3
the process of the practitioner developing his/her own techniques. Some of these will be given in
this manual.
The output level settings appropriate for the various electrosurgical procedures are the first and
most important parameters to be determined by the practitioner. The settings used by the devel-
opers of these techniques are given in their published papers. (Some of these papers are listed in
the Bibliography section of this manual.) However, these published results were obtained using
different electrosurgical generators. Every generator has its own cutting characteristics that may
not be exactly duplicated by another generator using the same settings. Furthermore, the charac-
teristics of the excision are dependent not only upon the output setting, but also upon the length
and thickness of the cutting electrode, the moisture content and type of tissue, and the speed of
the cut. Always use the lowest possible setting which achieves the desired excision quality
and speed.
The new user should develop confidence in the combination of the generator's characteristics and
his/her own technique by practicing extensively on pieces of chicken breast or beef tongue. The
objective of this practice is to determine the natural speed of the cutting electrode through the
tissue at various output settings, and to observe how the depth of the thermal damage is influ-
enced by the speed of the cut, the cut or blend mode selected, and the output setting used. After
sufficient practice is obtained, the clinician should be able to develop the confidence and skill
necessary to practice these procedures on patients using electrodes of different sizes and configu-
rations for various procedures. Practitioners who prefer a slow cut, using a small electrode, or
excising a small amount of tissue should use settings at the lower end of the output range. Those
who prefer a faster cut, using a large electrode, or excising a large amount of tissue should use
settings at the upper end of the output range. The cutting power required is dependent on many
factors such as:
1. Nature of tissue to be excised. Fatty or cartilaginous tissues require higher power output than
muscle or skin tissue. Sclerotic, fibrotic, or cicatrical tissues require higher power output than
softer tissues.
2. Depth of excision. A deep excision (with the same electrode and speed of cut) requires a
higher power output than a shallow incision.
3. Rate of speed at which the cutting electrode is moved. The faster the speed of the wire
through the tissue during the cut requires higher power outputs than at slower speeds.
4. Type of electrode used. For a given depth of excision with an equivalent cutting speed, the
longer wire requires higher power outputs than a shorter wire. Thicker wire requires higher
power outputs than a thinner wire.
5. Tissue moisture content. Drier tissue requires higher power output than moist tissue.
The FINESSE+ generator diminishes the effects of some of the above variables by means of its
feedback-controlled output. Because this circuit reduces the output power applied at the begin-
ning and end of the cut to the minimum levels needed, it is generally operated at somewhat high-
er nominal output settings than most generators. The pure cut mode provides an excision with
little hemostasis effect. Blend 1 provides an excision with minimal hemostasis effects. Blend 2

4FINESSE+ Service Manual
provides an excision with average hemostasis effect. Blend 3 provides an excision with maximum
hemostasis effect.
Coagulation of bleeding vessels after completion of an excision is usually accomplished using a
ball electrode in the coagulation mode. In this mode, the ball electrode will throw sparks to the
surface of the tissue with slight separation of the ball from the surface. This process, known as
fulguration coagulation, should be done briefly to stop any bleeding that occurs. It should not be
overdone. Other hemostatic techniques use the ball in contact with the tissue surface to coagu-
late by desiccation with little or no sparking. Desiccation techniques may cause unnecessarily
deep thermal damage if not performed carefully. As with cutting, coagulation should be practiced
on appropriate tissue simulators before performing the procedure on a patient. The coagulation
power required is dependent on many factors such as:
1. Length of time the current is applied. Lower power outputs applied for longer periods produce
a greater depth of coagulation than higher outputs applied for a shorter period of time.
2. Type of electrode used. A ball electrode will require a higher power setting than pointed elec-
trodes, due to the larger area of tissue contact.
3. Character of surrounding media. Higher power outputs are required for coagulation under
water or in a bloody field than for coagulation in relatively dry operative sites.
For typical LETZ procedures, cutting mode output settings ranging from "40" to "70" have been
found to be effective, with a setting of "65" typically used. Coagulation mode output settings
ranging from "40" to "75" have been found to be effective in providing hemostasis for bleeding
vessels, with a setting of "60" typically used.
Operational Safety Notes and Warnings
The FINESSE+ system has been designed to implement the best principles of electrical safety. The
remaining burden for patient and operator safety lies with the user of the device. The most
important safety factors that are under control of the operator are delineated below. It is impor-
tant that these points, as well as others made throughout this manual, be read and understood
before performing surgery with this instrument.
Inspection. When the system is unpacked after transport between locations, as well as periodi-
cally with ordinary use, visually inspect the FINESSE+ system, accessories, accessory receptacles,
power cord, and power cord receptacle for damage or missing parts. Do not use the system with-
out correcting any observed or suspected damage.
WARNING: No modification of this equipment is allowed. Modification of the
FINESSE+ may expose operator and/or patient to hazardous electrical currents.
Dispersive electrode pad. Always apply the dispersive pad as indicated in the dispersive pad
instructions for use. Directions are provided with the dispersive pads. These directions should be
rigorously followed to prepare, apply, maintain, and remove the dispersive electrode, and periodi-
cally make a visual check of the pad application to the patient.
To ensure safe contact of the dispersive pad to the patient, use only pads listed as compatible
with the FINESSE+'s CQM system. The use of contact monitoring pads that are not on the list in

FINESSE+ Service Manual 5
the Technical Specifications section of this manual may not properly signal an error condition and
result in patient injury.
If the patient moves after application of the dispersive electrode, the contact between the elec-
trode and the patient should be rechecked before proceeding with the surgical procedure.
Skin-to-skin contact (e.g. — between the arms and body of the patient) should be avoided, for
example, by the insertion of dry gauze. This practice aids in preventing the establishment of alter-
nate current paths.
Grounding. At the frequencies and power levels used in electrosurgery, any grounded metal parts
may conduct current away from the patient with sufficient concentration at the contact point to
cause a burn. Although the isolated lead system of this generator is usually effective in limiting
this leakage current and preventing such burns, there are circumstances where this precaution
may be accidentally subverted and stray currents may flow. Therefore, the patient should not
come into contact with metal parts which are grounded or which have an appreciable capacitance
to ground (e.g. operating table, supports, etc.). The use of antistatic sheeting is recommended for
this purpose.
Jewelry. Jewelry can concentrate electrosurgical current if placed in the vicinity of the electro-
surgical procedure or in the general path that the electrosurgical current would follow, for exam-
ple, the path between the surgical site and the dispersive electrode. Also, loose fitting jewelry
may come into contact with objects that could enable an alternate current path. Any of these
conditions could cause patient shock or burn. Jewelry should be removed or isolated by dry gauze
as much as possible.
Leads. Unshielded active and return leads should be positioned so that they cannot come into
contact with the patient or with other leads connected to the patient. They should also not be
allowed to run closely parallel to other leads.
Monitoring Leads. Electrodes and probes connected to monitoring, stimulating, or imaging
devices (e.g. ECG electrodes) can provide paths for stray electrosurgical currents which may cause
burns. This is possible even though these electrodes and probes are battery operated, insulated, or
isolated at 50Hz/60Hz. The risk can be minimized by placing the electrodes or probes as far away
from the surgical site and dispersive electrode as possible. Protective impedances in the monitor-
ing leads can help reduce the risk of burns. Electrodes covering wide areas are best, and needle-
type monitoring electrodes should never be used during electrosurgery. In all cases, monitoring
systems incorporating high frequency current limiting devices are recommended.
Active Electrode. The surgeon handling the active electrode must, of course, avoid applying the
active electrode to any point on his/her own body. The surgeon must also be aware that if the
active electrode is touched to any conductive tool or appliance, that device becomes an extension
of the active electrode and can cause burns to either the patient or the surgeon. When not being
used, the active electrode should be stored isolated from the patient.
Monopolar Electrosurgery. The FINESSE+ system is a monopolar type electrosurgical system.
For surgical procedures where the HF current could flow through parts of the body having rela-
tively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid
unwanted tissue damage.

6FINESSE+ Service Manual
Accessories. Any reusable accessories should be periodically tested for function and safety in
accordance with their manufacturers' instructions. Use only accessories whose connectors match
those on the generator. Adaptors should not be used unless they are approved by Utah Medical
Products as being compatible with the FINESSE+.
The FINESSE+ system should only be used with the accessories that are offered by Utah Medical
Products. However, it should be noted that certain accessories may appear to be physically com-
patible with the FINESSE+ system, but may not comply with quality and performance regulations,
and as such may limit or impede the intended performance and safety features of the FINESSE+
system.
To ensure that the FINESSE+ system complies with electromagnetic emissions and immunity regu-
lations, users should use only the switchpens and dispersive pads listed in the Accessories section
of this manual. Under no circumstances should switchpen cables exceed 10 ft (3m) in length, and
dispersive pad cables should never exceed 10 ft (3m) in length. The use of accessories with longer
cable lengths may result in increased emissions or decreased immunity of the FINESSE+ system.
Only use active electrodes and pencils that have Rated Accessory Voltage greater than the
Maximum Output Voltage for the selected output setting and mode (see Table 1 and Figure 8 in
the Technical Specifications section).
Power Deficiencies. The output setting selected should be appropriate for the intended purpose
(see the section titled "Electrosurgical Procedure Guidelines"). Always use the lowest possible
setting which achieves the desired excision quality and speed. An apparent power deficiency
in cutting or coagulation may indicate faulty application of the dispersive electrode or failure of a
patient lead. It may also result from attempting to push the electrode through the tissue faster
than the natural speed of the electrode for the output level set inside the generator. If a slower
cut does not produce the desired results, then the patient circuit, including the active and disper-
sive electrodes, should be checked before increasing the output settings.
Sparks. The sparks generated in electrosurgical cutting or coagulation can easily ignite flammable
substances at the surgical site. The use of flammable anesthetics or oxidizing gases such as
nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the
region of the thorax or the head, unless these agents are drawn away. Non-flammable agents
should be used for cleaning and disinfection wherever possible. Flammable agents used for clean-
ing or disinfection or as solvents of adhesives should be allowed to evaporate before the applica-
tion of the electrosurgical device. There is a risk of pooling of flammable solution under the
patient or in body depressions such as the umbilicus and body cavities such as the vagina. Any
fluid pooled in these areas should be removed before the electrosurgical equipment is used.
Attention should be called to the danger of ignition of endogenous gases. Some materials, for
example cotton wool and gauze, when saturated with oxygen may be ignited by sparks produced
in normal use of the electrosurgical generator.
Filters. After use, the external disposable filter can be a source of odor and possible viral con-
tamination. Also, using this filter for too many procedures may compromise its particle or odor
removal efficiency. For optimum performance, this filter should be discarded either daily or after
15 procedures if more than 15 procedures are performed in a single day. It should be removed