Bovie Smoke Shark III User manual

Smoke Shark™ III
Surgical Smoke Evacuator
Operator’s Manual
www.symmetrysurgical.com +1 615.964.5532 (International) 800.251.3000 (United States & Canada)

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
TABLE OF CONTENTS
Section Title Page
— DIAGRAM / CONTENTS 3
— GLOSSARY 4
1.0 DESCRIPTION/ INTRODUCTION 5
1.1 Introduction
1.2 Inspection
1.3 Operational Information
1.4 Cautions and Warnings
2.0 OPERATING INSTRUCTIONS 9
2.1 Control Panel
2.2 Set-up and Operation
2.3 Filter Instructions
2.4 Automatic Activation Device Instructions
2.5 Performance References
2.6 Electromagnetic Compatibility Information per IEC 60601-1-2
3.0 MAINTENANCE 16
3.1 General Maintenance Information
3.2 Cleaning
3.3 Periodic Inspection
3.4 Troubleshooting
4.0 CUSTOMER SERVICE 17
4.1 Product Return
4.2 Ordering Information
5.0 TERMS & WARRANTY 18

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
DIAGRAM / CONTENTS
120 Power Cord 220 Power Cord Automatic Activation Device
Service Indicator
(LED)
Filter Life Indicator
(LED)
Motor On Indicator
(LED)
Standby Indicator (LED)
CONTROL PANEL
FRONT
BOTTOM
Figure 1
Power Receptacle
Automatic Activation Device Port
Power Off / On Button
One-Port Filter with
Hidden Male Port
Suction On / Standby
Button
100/120V~
4 Amps
50/60 Hz
Model # SE03-120
Smoke Shark™ III
E351320
Medical – General
Medical Equipment as to Electrical Shock, Fire and
Mechanical Hazards only in Accordance with
ANSI/AAMI ES60601-1 (2005) and AMD 2 (2012),
CAN/CSA-C22.2 NO. 60601-1 (2014)
®
Rx ONLY
Bovie®products are exclusively distributed by:
Symmetry Surgical Inc. 3034 Owen Drive, Antioch, TN 37013
CAUTION – Grounding reliability can only be achieved when the equipment is connected
to a receptacle marked “Hospital Grade” or “Hospital Only”.
CONMED Corporation
525 French Road
Utica, NY 13502
905215 Rev A
EN Surgical Smoke Evacuator
FR Évacuateur de fumée chirurgicale
IT Evacuatore di fumi chirurgici
DE Chirurgische
Rauchabzugsvorrichtung
ES Evacuador quirúrgico de humos
EL Συσκευή εκκένωσης
χειρουργικού καπνού
PT Extrator de fumo cirúrgico
PT-BR Aspirador de fumaça cirúrgica
NL Chirurgische rookafzuiging
DA Kirurgisk røgsuger
SV Utsug för kirurgisk rök
FI Kirurgisen savun poistolaite
NO Kirurgisk røykavsug
ZH 外科手术排烟器
JA 外科用煙排出器
PL Chirurgiczny odsysacz dymu
TR Cerrahi Duman Tahliye Cihazı
RO Evacuator de fum chirurgical
ﻲﺣارﺟﻟا نﺎﺧدﻟا درﺎط AR
RU Устройство для удаления дыма
при хирургических процедурах
HR Kirurški evakuator dima
CS Odsávací přístroj na chirurgický
kouř
HU Sebészeti füstelszívó
LT Chirurginis dūmų evakuatorius
SK Chirurgický odvádzač dymu
SL Kirurški sistem za odstranjevanje
dima
KO 수술용 연기 흡인기
For applicable IFU, visit
www.boviemedical.com/medical-resources/

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
GLOSSARY
Name Description
AMP Ampere, unit of electric current
Automatic Activation Device Device used to remotely operate the Bovie® Smoke Shark Surgical Smoke
Evacuator to control the suction on/standby modes in conjunction with ESU
activation, saving lter life.
CISPR International Special Committee on Radio Interference
EMC Electromagnetic Compatibility
ESD Electrostatic Discharge
Filter Completely enclosed device where surgical smoke is processed through
four (4) stages of ltration.
Filter Life Indicator A visual status indication of the life of lter in use.
Grounded Electrical Outlet An electrical outlet, which in addition to the current-carrying contacts, has a
third contact that serves for connection to a grounding conductor. Devices
and equipment that are to benet from this safety feature must have an
appropriate three-prong plug that is inserted into this outlet. There are other
possible arrangements for such outlets, including the use of lateral grounding
contacts that make contact with metallic strips on the side of the plug. Also
called by various other names, including grounding outlet, ground outlet,
grounded receptacle, grounding receptacle, grounded socket, safety outlet, or
three-prong outlet.
IEC International Electrotechnical Commission
LED Light-emitting diode (LED) is a two-lead semiconductor light source that emits
light when activated.
Power Cord A cable used to connect the Surgical Smoke Evacuator to a grounded
electrical outlet.
Suction On/Standby Button Button to shift between two modes of suction control: on and standby.
Bovie®Smoke Shark
Surgical Smoke Evacuator.
Device with one or more lters designed to evacuate surgical smoke and
aerosol from the operative site, lter out the contaminants, and return ltered
air to the operating room.
VAC Volts Alternating Current

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
DESCRIPTION / INTRODUCTION: SECTION 1.0
1.1 Introduction
The Bovie®Smoke Shark Surgical Smoke Evacuator is intended to evacuate and filter surgical smoke and
aerosols created by the interface of surgical tools with tissue (examples: lasers, electrosurgery systems,
desiccators and ultrasonic devices).
The Bovie®Smoke Shark Surgical Smoke Evacuator has been designed to provide appropriate
suctioning, using a motor on /off button, to manage surgical smoke instruments. The ultra-quiet motor
is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the filter
where the surgical smoke is processed through four (4) stages of filtration. A single, completely enclosed,
disposable filter is used to simplify installation and removal during filter changes to protect healthcare
personnel from potential contamination during filter changes.
1. The first stage filtration utilizes a pre-filter to trap and remove gross particulate and casual fluid.
2. The second stage filtration is an ULPA grade (Ultra Low Penetration Air) filter with a high-tech
patented design that captures particulates and micro-organisms from 0.1 to 0.2 microns at 99.999%
efficiency.
3. The third stage filtration uses the highest grade virgin activated carbon. The activated carbon is
known to remove toxic organic gases and may provide optimal odor removal.
4. The fourth stage filtration is a woven fiberglass filtration media used to reduce the amount of
activated carbon fines from migrating out of the filters.
1.2 Inspection
The Bovie®Smoke Shark Surgical Smoke Evacuator was thoroughly tested and inspected prior to
shipment. Please inspect the Bovie®Smoke Shark Surgical Smoke Evacuator before using to ensure all
items have been received and that no damage occurred during transit. If items are missing or damage is
evident, please contact Customer/Technical Services.
Items Included:
• Operator’s Manual
• Filter
• Power Cord
• Automatic Activation Device
• Wall Mounting Kit
1.3 Operational Information
The operational information contained in this section is intended for customer review of technical
specifications. The information pertains to the use of the products both domestically and internationally:
1. Both the 100/120 VAC, 50/60 Hz and 220/240 VAC, 50/60 Hz Bovie®Smoke Shark Surgical Smoke
Evacuators comply with IEC60601-1 electrical specifications.
2. Type of protection against electrical shock (ANSI/AAMI ES 60601-1, Clause 6.1): Class I
3. Degree of protection against electric shock (ANSI/AAMI ES 60601-1, Clause 6.2): Type CF Applied Part
4. Degree of protection against ingress of water (ANSI/AAMI ES 60601-1, Clause 6.3): IPX0
5. Method of sterilization or disinfection recommended (ANSI/AAMI ES 60601-1, Clause 6.4):
Unplug Bovie®Smoke Shark Surgical Smoke Evacuator. Wipe Bovie®Smoke Shark Surgical
Smoke Evacuator with a damp cloth containing mild disinfectant solution or soapy water. Wipe
dry with a clean cloth. Do not steam sterilize.
6. Degree of safety of application in the presence of flammable anesthetic mixture with air or with
oxygen or nitrous oxide (ANSI/AAMI ES 60601-1, Clause 6.5): Not Suitable
7. Mode of operation (ANSI/AAMI ES 60601-1, Clause 6.6): Continuous

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
DESCRIPTION / INTRODUCTION: SECTION 1.0
8. The fuses are to be serviced by an authorized technician. Please call Technical Services.
100/120 VAC, 50/60 Hz use 4 AMP 250 Volt Fuse (Slo-Blo)
220/240 VAC, 50/60 Hz use 2 AMP 250 Volt Fuse (Slo-Blo)
9. The Bovie®Smoke Shark Surgical Smoke Evacuator requires special precautions regarding
Electromagnetic Compatibility (EMC) and needs to be installed according to EMC information found
in this manual.
10. To isolate the Bovie®Smoke Shark Surgical Smoke Evacuator from supply mains, unplug the Power
Cord from the power receptacle on the Bovie®Smoke Shark Surgical Smoke Evacuator or receptacle
in the wall. Position the equipment to allow for ease of unplugging the Power Cord.
11. The Bovie®Smoke Shark Surgical Smoke Evacuator and all filters are not intended for contact with
patients.
12. Type CF applied part – Pen-type (tubing) device for attachment to surgical cutting tool; no electrical
connection to unit.
1.4 Cautions and Warnings
All Cautions and Warnings should be read and understood before using the Bovie®Smoke Shark Surgical
Smoke Evacuator.
Attention: Consult Instructions Before Use.
1.4.1 WARNINGS:
The warranty on the Bovie®Smoke Shark Surgical Smoke Evacuator is void if any of the following
warnings are disregarded.
• Read this manual thoroughly and be familiar with its contents prior to using the Bovie®Smoke Shark
Surgical Smoke Evacuator.
• Confirm operational set-up of the Bovie®Smoke Shark Surgical Smoke Evacuator prior to a surgical
procedure.
• Disconnect the Bovie®Smoke Shark Surgical Smoke Evacuator from the grounded electrical outlet
prior to inspecting Bovie®Smoke Shark Surgical Smoke Evacuator components.
• The Bovie®Smoke Shark Surgical Smoke Evacuator is only intended and suitable for the applications
mentioned in the operating instructions.
• The Bovie®Smoke Shark Surgical Smoke Evacuator produces a strong vacuum. Position the inlet
end of the wand or tubing to prevent patient injury and to prevent suction of surgical materials and
specimens.
• To prevent patient injury, the tubing or wand should not come into direct contact with tissue.
• The filter and single-use accessories are completely disposable. Please dispose according to your
local codes or regulations and facility policy.
• Route Power Cord to prevent a tripping hazard or crimping of cords, which could cause unreliable
operation or electric shock.
• Position Automatic Activation Device and any other attached accessories to prevent a tripping hazard
or crimping of cords, which could cause unreliable operation.
• Do not operate the Bovie®Smoke Shark Surgical Smoke Evacuator in the presence of flammable or
explosive gases.
• The Bovie®Smoke Shark Surgical Smoke Evacuator is intended for use by healthcare professionals only.

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
DESCRIPTION / INTRODUCTION: SECTION 1.0
• The Bovie®Smoke Shark Surgical Smoke Evacuator may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation measures such as re-orienting
or relocating the Bovie®Smoke Shark Surgical Smoke Evacuator or shielding the location.
• The use of accessories other than those specified by the manufacturer as replacement parts for internal
components may result in increased emissions or decreased immunity of the Bovie®Smoke Shark
Surgical Smoke Evacuator
• Refer routine servicing to Symmetry Surgical. See Customer/Technical Services contact information.
• Changes or modifications not expressly approved by the manufacturer could void the warranty.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
1.4.2 CAUTIONS:
• United States Federal Law restricts the Bovie®Smoke Shark Surgical Smoke Evacuator to sale by or
on the order of a physician.
• Using any other filter or accessory not specified by the manufacturer may cause damage and/or
cause the Bovie®Smoke Shark Surgical Smoke Evacuator to be inoperable, voiding the warranty.
• Care must be exercised in the installation of tubing and adapters. Failure to follow the procedures
outlined in this manual may result in overheating of the motor and may void the warranty.
• The Bovie®Smoke Shark Surgical Smoke Evacuator is not intended for evacuation of fluid. Failure
to avoid fluid aspiration could cause filter blockage, electrical damage, decreased efficiency, and
possible internal contamination.
• The filter should be changed according to the Filter Life Indicator. The filter should not be used for
more than the filter life specified. Failure to change the filter may result in decreased efficiency and
possible internal contamination.
• Care must be exercised in the installation and removal of filter and tubing. Filter and tubing are used
to capture potentially hazardous materials. Failure to follow the procedures outlined in this manual
may result in possible internal contamination.
• Do not block the tubing during operation. An occlusion or significant restriction may cause the motor
to overheat and the Bovie®Smoke Shark Surgical Smoke Evacuator to stop working.
• Installation of the Bovie®Smoke Shark Surgical Smoke Evacuator must be performed such that the
intake and exhaust vents located on the rear of the system are not obstructed. Failure to properly
install the Bovie®Smoke Shark Surgical Smoke Evacuator may cause reduced performance, damage,
and/or cause the Bovie®Smoke Shark Surgical Smoke Evacuator to be inoperable, voiding the
warranty.
• The ambient temperature during operation must be kept between 50°F to 104°F (10°C to 40°C).
• The relative humidity during operation must be kept between 10% to 75%.
• An atmospheric pressure range during operation must be kept between 700 hPa to 1,060 hPa.
• Storage environmental ambient temperature should be kept between 14°F to 140°F (-10°C to 60°C).
• Storage environmental relative humidity should be kept between 10% to 75%.
• There are no user serviceable components in the Bovie®Smoke Shark Surgical Smoke Evacuator.
Refer to Symmetry Surgical Customer/Technical Services for routine servicing.
• Use only with the Power Cord provided and always plug into a grounded electrical outlet.

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
DESCRIPTION / INTRODUCTION: SECTION 1.0
Symbol Description / Meaning Symbol Description / Meaning
DANGER HIGH VOLTAGE
CAUTION - ELECTRICAL SHOCK
HAZARD. DO NOT REMOVE
COVER.
REFER SERVICING TO QUALIFIED
SERVICE PERSONNEL.
MARKING OF EEE (ELECTRICAL
AND ELECTRONIC EQUIPMENT).
FOLLOW LOCAL REQUIREMENTS
FOR PROPER DISPOSAL.
DANGER
CAUTION - RISK OF EXPLOSION IF
USED IN THE PRESENCE OF
FLAMMABLE ANESTHETICS.
CAUTION: FEDERAL LAW (USA)
RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A
PHYSICIAN
WARNING
CONSULT INSTRUCTIONS/
DIRECTIONS FOR
USE
CAUTION
MD
MEDICAL DEVICE
TYPE CF APPLIED PART LATEX NOT MADE WITH NATURAL
RUBBER LATEX
ALTERNATING CURRENT CE MARK
PROTECTIVE EARTH, (GROUND) EC REP
AUTHORIZED REPRESENTATIVE
IN THE EUROPEAN COMMUNITY
FOR CE MARKED DEVICES.
DENOTES THE DATE
THE EQUIPMENT WAS
MANUFACTURED
SN SERIAL NUMBER
DENOTES THE MANUFACTURER
OF THE DEVICE
DO NOT USE IF PACKAGE IS
DAMAGED
NON-IONIZING RADIATION
SERVICE INDICATOR
CONTACT CUSTOMER/TECHNICAL
SERVICES

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
2.1 Control Panel (see Figure 1, Diagram/Contents)
The Control Panel contains the following LED indicators: Motor On, Standby, Filter Life, and Service.
Read all instructions before operating the Bovie®Smoke Shark Surgical Smoke Evacuator or installing
accessories. Failure to do so may result in damage to the Bovie®Smoke Shark Surgical Smoke
Evacuator and/or personal injury.
POWER OFF / ON
To power up the Bovie®Smoke Shark Surgical Smoke Evacuator, connect the supplied Power Cord to a
grounded electrical outlet and the power receptacle at the bottom of the Bovie®Smoke Shark Surgical Smoke
Evacuator. Flip the Power Off / On Button to “ON” to apply power to the unit. Once power has been applied,
the Standby Indicator LED illuminates the color amber. Turn the Bovie®Smoke Shark Surgical Smoke
Evacuator main power off by either flipping the Power Off/ On Button to “OFF” or by unplugging the Power
Cord from either the power receptacle on the Bovie®Smoke Shark Surgical Smoke Evacuator or the
grounded electrical outlet.
SUCTION ON / STANDBY BUTTON
Press the Suction On/Standby Button to shift between two (2) modes: On or Standby. The Suction On
LED illuminates the color green indicating active suction and the Standby LED illuminates the color amber
when in standby.
Filter LIFE INDICATOR
The Filter Life Indicator on the Control Panel provides a visual indication of the status of the filter life of the
filter in use.
Install an unused filter into the Bovie®Smoke Shark Surgical Smoke Evacuator as per the installation
instructions (section 2.3). When the Motor On LED is illuminated, the Filter Life Indicator will light up the
uppermost green LED indicating 100% Filter Life. The indicator will progress through subsequent colors,
from green LEDs to amber LED as time elapses, and finally to red to indicate the filter has expired and
requires replacement. When the maximum filter life is expended: The unit will cease operation in one
(1) hour or when the unit is manually powered off, whichever
occurs first. The smoke evacuator will not resume functionality
until a new filter is installed. The filter has a 6 hour lifetime which
is automatically tracked by the Bovie®Smoke Shark Surgical
Smoke Evacuator.
2.2 Set-Up and Operation
1. Mount the Bovie®Smoke Shark Surgical Smoke Evacuator
using the wall mounting kit (SE03-M). Secure the wall
mounting kit to the wall by drilling two 3/8” diameter holes
in wall, installing the provided hardware into the holes,
and secure mounting plate to the provided hardware. The
Bovie®Smoke Shark Surgical Smoke Evacuator can be
secured to the wall mounting kit (SE03-M) by sliding the
two screws protruding from the rear of the Bovie®Smoke
Shark Surgical Smoke Evacuator (Figure 2.) into the grooves found on the mounting kit (SE03-M).
2. Attach the Power Cord to the power receptacle on the bottom of the Bovie®Smoke Shark Surgical
Smoke Evacuator and into a grounded electrical outlet. Route Power Cord to prevent a tripping
hazard or crimping of cords, which could cause unreliable operation or electric shock.
Figure 2

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
3. Install the filter (see filter installation instructions, section 2.3).
4. The Automatic Activation Device may also be installed by plugging it into the Automatic Activation
Device port located on the front of the Bovie®Smoke Shark Surgical Smoke Evacuator. See section
2.4 for instructions.
5. Ensure that any smoke evacuation capture accessory is fully installed in the filter port.
6. Route any other attached accessories to prevent a tripping hazard or crimping of cords, which could
cause unreliable operation.
7. Activate the Bovie®Smoke Shark Surgical Smoke Evacuator by one of the following:
• Pressing the Suction On/Standby Button on the Control Panel of the smoke evacuator.
• Utilizing the automatic activation accessory provided with the unit. This device will synchronize
the activation of the smoke evacuation unit with the activation of the desiccator device.
8. Deactivate the Bovie®Smoke Shark Surgical Smoke Evacuator by one of the following:
• Pressing the Suction On/Standby Button on the Control Panel of the smoke evacuator.
• Releasing the pencil button on the desiccator device if an automatic activation device
is being used.
9. Replace the filter when the Filter Life Indicator flashes the color red (0% life remaining). Failure to
change the filter will affect the performance of the Bovie®Smoke Shark Surgical Smoke Evacuator.
2.3 Filter Instructions
Bovie®P/N: SF06
Configuration: Wall Mounted
Bovie®SF06 Filter: 4-Stage Filtration In One Casing, (Pre-Filter, ULPA, Carbon, Post-Filter)
Filter(s): ULPA
Particle Size, µm: 0.1 to 0.2 Microns At 99.999% Efficiency
Filter Life: 6 hours, Automatic Factory Set Filter Sensor
Filter Life Indicator: Time Replacement
Filter Installation Instructions:
Note: Before installing or removing any filter, be sure that the Bovie®Smoke Shark Surgical Smoke
Evacuator is placed in the Standby mode by pressing the Suction On/Standby Button.
1. Remove the filter from the shipping box and discard any protective wrapping.
2. Inspect the filter for damage, which may have occurred during shipping and storage. Do not install any
filter with visible signs of structural damage.
3. Insert the filter into the filter chamber and ensure the filter is installed completely against the bottom of
the filter chamber.
Filter Removal Instructions:
1. After the filter life has expired, turn the Bovie®Smoke Shark Surgical Smoke Evacuator to the Standby
mode by pressing the Suction On/Standby Button.
2. Remove all accessories attached to the filter.
3. Remove the Filter from the Bovie®Smoke Shark Surgical Smoke Evacuator. Dispose according to your
local codes or regulations and facility policy (Section 3.2).
4. Clean the Bovie®Smoke Shark Surgical Smoke Evacuator with a mild disinfectant prior to re-use and
follow the indicated instructions for maintenance and installation of a new filter (Section 3.2).

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OPERATING INSTRUCTIONS: SECTION 2.0
2.4 Automatic Activation Device Instructions
1 2 3 4
5 6 7 8
0 sec. – 10 sec. Delay.
Clean with
alcohol.
2.5 Performance References*
Performance
Model Name/ Number Bovie®Smoke Shark III / SE03-120 & SE03-220
Maximum Flow Setting (LPM-U.S.)
Standard Hose I.D. 9.5 mm, 3/8”
SharkSkin Adapter 45 LPM
Dimensions (H x W x D ) inches 10 x 7 x 7.5
Dimensions (H x W x D ) centimeters 25.4 x 17.8 x 19.1
Weight lbs 7.0
Weight kg 3.2
Noise Level, dBA maximum 55 dBA (120 V), 62 dBA (220 V)
Voltage Available 100/120 VAC, 220/240 VAC
Frequency, auto sensed 50/60 Hz
Remote Control Activation: Yes (optional)
Safety Features: UL Classied, CE Marked, Fuse Protection
Display: LED, Filter Status, Suction On/Off, Service Required
*For reference purposes only

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
2.6 Electromagnetic Compatibility Information per IEC 60601-1-2
Table 1
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The Bovie®Smoke Shark Surgical Smoke Evacuator is intended for use in the electromagnetic environment
specied below. The customer or user of the Bovie®Smoke Shark Surgical Smoke Evacuator should ensure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1 The Bovie®Smoke Shark Surgical Smoke Evacuator uses RF
energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby
electronic equipment.
RF Emissions
CISPR 11
Class A The Bovie®Smoke Shark Surgical Smoke Evacuator is suitable for
use in all establishments, other than domestic establishments and
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A Not applicable.
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Class A Not applicable.

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
Table 2
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Bovie®Smoke Shark Surgical Smoke Evacuator is intended for use in the electromagnetic environment
specied below. The customer or user of the Bovie®Smoke Shark Surgical Smoke Evacuator should ensure
that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level Electromagnetic Environment - Guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+2 kV for power
supply lines
+1 kV for input/
output lines
+2 kV for power
supply lines
+1 kV for input/
output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+1 kV differential
mode
+2 kV common
mode
+1 kV differential
mode
+2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines.
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the Bovie®Smoke Shark
Surgical Smoke Evacuator requires continued
operation during power main interruptions,
it is recommended the Bovie®Smoke Shark
Surgical Smoke Evacuator be powered from
an uniterruptible power supply or a battery.
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in
UT) for 5 sec
Power frequency
(50/60 Hz) magnetic
eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.

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905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
Table 3
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The Bovie®Smoke Shark Surgical Smoke Evacuator is intended for use in the electromagnetic environment
specied below. The customer or user of the Bovie®Smoke Shark Surgical Smoke Evacuator should ensure
that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Bovie®Smoke Shark Surgical
Smoke Evacuator including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Radiated RF 3 V/m d = 1.7 √P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5
GHz
3 V/m d = 2.3 √P 800 MHz to 2.5 GHz
3 Vrms d = [3.5/V1} √P
Conducted RF Where P is the maximum output power rating
of the transmitter in Watts (W) according to
the transmitter manufacturer and D is the
recommended separation distance in meters (M).
IEC 61000-4-6
150 kHz to 80
MHz
Field strength from xed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structure, objects and people.
Field strengths from xed 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 predicted
theoretically with accuracy.
To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the Bovie®Smoke Shark
Surgical Smoke Evacuator is used exceeds the applicable RF compliance level above, the Bovie®Smoke
Shark Surgical Smoke Evacuator should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Bovie®Smoke Shark Surgical Smoke Evacuator.
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 15
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
OPERATING INSTRUCTIONS: SECTION 2.0
Table 4
Recommended Separation Distance Between
Portable and Mobile RF Communications Equipment and
the Bovie®Smoke Shark Surgical Smoke Evacuator @ 3 Vrms
The Bovie®Smoke Shark Surgical Smoke Evacuator is intended for use in the electromagnetic environment
in which radiated RF disturbances are controlled.
The customer or the user of the Bovie®Smoke Shark Surgical Smoke Evacuator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Bovie®Smoke Shark Surgical Smoke Evacuator as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
3.5
d = √P
v1
80 kHz to 800 MHz
3.5
d = √P
E1
800 kHz to 2.5 GHz
3.5
d = √P
E1
0.01 0.12 0.12 0.23
0.1 0.34 0.34 0.74
1 1.7 1.7 2.3
10 3.7 3.7 7.4
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation Distance
(D) in Meters (M) can be estimated using the equation applicable to the frequency of the transmitter, where
(P) is the maximum output 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 reection from structure, objects, and people.
[][][]

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 16
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
MAINTENANCE: SECTION 3.0
3.1 General Maintenance Information
It is recommended that periodic inspection and performance testing be completed by a qualified facility
biomedical technician to ensure continued safe and effective operation.
3.2 Cleaning
• Unplug the Bovie®Smoke Shark Surgical Smoke Evacuator.
• Wipe Bovie®Smoke Shark Surgical Smoke Evacuator with a damp cloth containing mild disinfectant
solution or soapy water.
• Wipe Bovie®Smoke Shark Surgical Smoke Evacuator with a dry clean cloth.
• Do not steam sterilize.
3.3 Periodic Inspection
The Bovie®Smoke Shark Surgical Smoke Evacuator should be visually inspected at least once per year.
The inspection should include checks for:
• Damage to the Power Cord or Power Inlet Module.
• Obvious external or internal damage to the Bovie®Smoke Shark Surgical Smoke Evacuator.
FUSES
Two 4 AMP fuses for 100/120 Bovie®Smoke Shark Surgical Smoke Evacuators or two 2 AMP fuses for
220/240 Bovie®Smoke Shark Surgical Smoke Evacuators are located within the housing of the system.
The fuses electrically protect both the Bovie®Smoke Shark Surgical Smoke Evacuator and the operator
from damage or injury. If the Bovie®Smoke Shark Surgical Smoke Evacuator is overheated or if there
is an electrical surge, fuses will break and the Bovie®Smoke Shark Surgical Smoke Evacuator will not
operate. No parts are user serviceable. When the Service LED Light Indicator illuminates, please contact
Customer/Technical Services.
3.4 Troubleshooting
PROBLEM POTENTIAL CAUSE CORRECTIVE ACTION
1. Bovie®Smoke
Shark Surgical
Smoke Evacuator
is on but suction is
minimal or none.
1. Filter is not seated
completely.
1. Re-install the lter, press rmly into place.
2. Filter is clogged. 2. Replace the lter with the manufacturer’s lter.
(SF06)
3. Vacuum tubing is
clogged.
3. Replace vacuum tubing with manufacturer’s
products.
4. Motor is obstructed. 4. Call Symmetry Surgical Customer Service.
2. Bovie®Smoke
Shark Surgical
Smoke Evacuator
does not function
even though Suction
On/Standby Button
is depressed.
1. Not plugged into an
electrical outlet.
1. Check the grounded electrical outlet connection and
the power receptacle located at the bottom of the
Bovie®Smoke Shark Surgical Smoke Evacuator.
2. Fuses are blown. 2. Call Symmetry Surgical Customer Service.
3. Electronic Bovie®
Smoke Shark Surgical
Smoke Evacuator failure.
3. Call Symmetry Surgical Customer Service.
4. Filter Life has expired or
invalid lter installed.
4. Replace the lter.

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 17
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
CUSTOMER SERVICE: SECTION 4.0
Report complaints involving this device to [email protected] or to your local
distributor.
4.1 Product Return
For the quickest response to your service needs, please follow these procedures:
Step 1: Write down Bovie®Smoke Shark Surgical Smoke Evacuator model name and serial number.
Step 2: Call Customer/Technical Services: 800.251.3000 (United States) or
+1 615.964.5532 (International) and describe the problem.
Step 3: If the problem cannot be resolved over the phone and the Bovie®Smoke Shark Surgical Smoke
Evacuator must be returned for repair, a Return Material Authorization (RMA) number must
be obtained from Customer Service before returning the Bovie®Smoke Shark Surgical Smoke
Evacuator.
Step 4: Use the original packaging material to return your Bovie®Smoke Shark Surgical Smoke
Evacuator whenever possible. If you do not have the original packaging material, ask Customer
Service for advice on how to pack for return shipment.
Step 5: Freight for all returned products should be prepaid by the facility returning the product.
A Ship To address will be supplied by Customer Service.
4.2 Ordering Information
To reorder, obtain replacement parts, or to return Bovie®Smoke Shark Surgical Smoke Evacuator, call
Customer Service or contact your authorized Distributor/Sales Representative.
Available accessories:
• Replacement filters (SF06)
• Replacement Automatic Activation Device (SERS2)
• Tubing (Various)
• Reducer Fittings (Various)
• Electrosurgical Pencil Adapter (SS95)

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 18
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
TERMS & WARRANTY: SECTION 5.0
5.1 Terms & Warranty
SPECIFICATIONS
Specifications are subject to change without notice.
SHIPMENT OF ORDER
Symmetry Surgical, Inc. will try to accommodate individual customer requests for shipping method.
Symmetry Surgical, Inc. reserves the right to decide shipping method on prepaid orders. Care is
exercised in the checking and packaging of all merchandise to avoid error, but should discrepancies
arise, claims should be made within 24 hours after delivery.
Symmetry Surgical, Inc.’s responsibility ceases with the safe delivery to the carrier at our dock.
If the merchandise is damaged in transit, a claim must be made to the carrier involved. Symmetry
Surgical, Inc. will assist customers in pursuing these claims.
RETURN OF MATERIAL
All returned merchandise must have a pre-authorized Return Material Authorization (RMA) from
Symmetry Surgical, Inc. and be marked with that RMA number prior to returning. Transportation costs
must be prepaid by the shipper and all risk of loss and damage of goods are the responsibility of the
shipper. Unauthorized returns will be refused. Include a copy of the packing papers and/or invoice with
the return. Exchange will be of an equivalent dollar value of returned merchandise less a restocking and
handling fee of new, unused, unopened equipment or disposables.
EXCEPTIONS
• Defective merchandise may be returned for replacement only.
Please contact Symmetry Surgical Customer Service before shipping back merchandise.
• Incorrectly shipped merchandise is exempt from restocking fees.
Please contact Symmetry Surgical Customer Service before shipping back merchandise.
WARRANTY
Symmetry Surgical, Inc. warrants that the Bovie®Smoke Shark Surgical Smoke Evacuator manufactured
by Symmetry Surgical, Inc. shall be free from defects in material and workmanship. Products are
warranted only to the extent that Symmetry Surgical, Inc. will replace without charge any Bovie®Smoke
Shark Surgical Smoke Evacuator proven to have defects within two (2) years of the date of delivery
of Surgical Smoke Evacuator and provided Symmetry Surgical, Inc. has been given the opportunity to
inspect the Surgical Smoke Evacuator alleged to be defective and the installation or use thereof. No
warranty is included for incidental or consequential damages of any nature arising from any defect. The
warranty above is the only warranty made by Symmetry Surgical, Inc. and is expressly in lieu of all other
warranties, expressed or implied, including, without limitation, the warranties of merchantability and
fitness for a particular purpose. All warranties implied by any course of dealing or usage between parties
are expressly excluded.

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 19
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
TERMS & WARRANTY: SECTION 5.0
Limitation of Liability for Damages. Symmetry Surgical, Inc. is not liable for indirect, special, incidental
or consequential damages of any kind, arising from any theory, including breach of warranty, breach of
contract, negligence, tort or any other legal theory. Such damages include but are not limited to, loss of
profits or revenues, loss of use of the Product or any associated equipment, cost of capital, cost of any
substitute Product, facilities or services, down-time costs, lost reputation, or claims of customers for such
damages. Notwithstanding anything to the contrary herein, the total limit of Symmetry Surgical, Inc.’s
liability under any theory for one or more claims shall not exceed, in the aggregate, the amount paid
to Symmetry Surgical, Inc. for the Product that is the subject of such claim. Purchase and use of the
Product associated with this IFU constitutes acceptance of this provision and all others in the IFU.
Entire Agreement and Amendment. All exhibits and schedules attached hereto and referenced herein
are made a part of this Agreement. This Agreement constitutes the entire agreement between the parties
concerning the subject matter of this Agreement and supersedes all prior negotiations and agreements
between the parties concerning the subject matter of this Agreement. The terms of any purchase order,
invoice, or similar document used to implement this Agreement shall be subject to and shall not modify
this Agreement. This Agreement may only be amended by a written agreement signed by both parties.
Warranties. All warranties provided by Symmetry Surgical, Inc. with respect to any Product sold are
as described in the package inserts or instructions for use available with the Product or on the www.
symmetrysurgical.com or www.boviemedical.com websites. OTHER THAN AS SET FORTH IN THE
PREVIOUS SENTENCE, THERE IS NO IMPLIED OR EXPRESS WARRANTY ON THE PRODUCTS,
INCLUDING THOSE OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Using
any filter not distributed by Symmetry Surgical, Inc. may cause damage to the Surgical Smoke Evacuator
and will void all warranties.
Governing Law, Venue and Jurisdiction. Any dispute arising from or related in any way to this IFU, the
product(s) associated with it or described herein shall be governed by and construed in all respects
in accordance with the laws of the state of Tennessee in the United States of America. All claims or
differences or other disputes, which arise out of or in connection with this IFU, the product(s) related to
it or otherwise shall be settled, litigated, or resolved by the state or federal courts in Antioch, Tennessee
(or those serving Antioch, Tennessee), and the parties hereby submit to the exclusive jurisdiction of such
courts over any dispute. All proceedings shall be held in English. Each party will bear its own costs in
such proceedings.

Customer/Technical Services: 800.251.3000 (United States) or +1 615.964.5532 (International) Page 20
905214 Rev A Bovie®Smoke Shark III Operator’s Manual
For a period of two (2) years following the date of delivery, Symmetry Surgical, Inc. warrants the
SmokeShark Surgical Smoke Evacuator against any defects in material or workmanship. Symmetry Surgical, Inc.
will repair or replace (at Symmetry Surgical’s option) the same without charge, provided that routine maintenance
as specied in this manual has been performed using replacement parts approved by Symmetry Surgical, Inc.
This warranty is void if the product is used in a manner or for purposes other than intended.
Bovie®products are exclusively distributed by:
Symmetry Surgical, Inc.
3034 Owens Drive
Antioch, TN 37013, USA
USA & Canada 800.251.3000
Fax [phone]
The revision level of this manual is specied by the highest revision letter
found on either the inside front cover or enclosed errata pages (if any).
Manual Number 905214 Rev A 07/2020
Unit Serial Number ______________________________
MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
CONMED Corporation
525 French Road
Utica, NY 13502-5994 USA
E351320
Medical – General
Medical Equipment as to Electrical Shock, Fire and Mechanical Hazards only in Accordance with
ANSI/AAMI ES60601-1 (2005) and AMD 1 (2012), CAN/CSA-C22.2 NO. 60601-1 (2014)
________________________________________________