make !hark Smoke Evacuator Operator’s Manual © 2015 Bovie Medical Corporation 5115 Ulmerton Road Clearwater, Florida 33760 US Phone: 1.800.537.2790 Fax: 1.800.323.1640 International Phone: +1 727 384 2323 www.boviemed.com

For a period of two (2) years following the date of delivery, Bovie Medical Corporation warrants the Smoke Shark II against any defects in material or workmanship. Bovie Medical Corporation will repair or replace (at Bovie Medical Corporation’s option) the same without charge, provided that routine maintenance as specified in this manual has been performed using replacement parts approved by Bovie Medical Corporation. This warranty is void if the product is used in a manner or for purposes other than intended. © 2015 Bovie Medical Corporation 5115 Ulmerton Road Clearwater, Florida 33760 US Phone:...

Table of Contents & List of Illustrations Section Title Page 1.0 SYSTEM DESCRIPTION 3 1.1 Introduction 1.2 Inspection 1.3 Operational Information 1.4 Cautions and Warnings 2.0 2.1 2.2 2.3 2.4 OPERATING INSTRUCTIONS System Controls Bovie® SF35 Filter Instructions Set-up and Operation Specifications MAINTENANCE General Maintenance Information Cleaning Periodic Inspection Troubleshooting CUSTOMER SERVICE Equipment Return Ordering Information 5.0 TERMS & WARRANTY 23 Figure Title Page 1 Control Panel 10 Smoke Shark II Operator’s Manual: Page 2

System Description Section 1.0 Bovie® Smoke Shark II Smoke Evacuation Systems are intended to evacuate and filter surgical smoke plume and aerosols created by the interface surgical tools with tissue, examples being lasers, electrosurgery systems, and ultrasonic devices. The Smoke Shark II Smoke Evacuation Systems have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Bovie® SF35 Filter where the surgical smoke is processed by a series of filters. A single disposable...

In addition, please compare the accessories you receive with the standard accessories list below. If an item is missing, please notify Bovie Medical Corporation Customer Service. Standard Accessories: • Operator’s Manual • Power Cord • Pneumatic Footswitch Please contact Bovie Medical Corporation Customer Service to purchase the following accessories: • Replacement Filters • Remote Activation Device • Hoses, Tubing, Laparoscopic Kits, Adapters, Wands & Other Accessories 1.3 Operational Information The operational information contained in this section is intended for the customer review of regulatory...

10. The fuses on the motor circuit are to be serviced by an authorized Bovie Medical Corporation technician as follows: 220/240 VAC, 50/60 Hz – use F3.15AH250V Fuse (3,15 Amp 250 Volt [Fast-Acting]), (F3) 11. This equipment needs special precautions regarding ElectroMagnetic Compatibility and needs to be installed according to EMC information found in this manual. 12. This equipment utilizes mobile RF communications equipment that can affect medical electrical equipment. 13. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of...

1.4.1 WARNINGS: • Read this manual thoroughly, and be familiar with its contents prior to using this equipment. • Test this equipment prior to a surgical procedure. This product was thoroughly tested at the factory before shipment. • Disconnect the unit from the electrical outlet prior to inspecting system components. • The Smoke Shark II system is only intended and suitable for the applications that are mentioned in the operating instructions. • The smoke evacuator produces a strong vacuum. Adjust the airflow and the position of the inlet end of the wand or tubing to prevent patient injury and...

• This equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Smoke Shark II should be observed to verify normal operation in the configuration in which it will be used. • Refer routine servicing to qualified biomedical technical personnel. • Changes or modifications not expressly approved by Bovie Medical Corporation could void the user’s authority to operate the equipment. The warranty on this product is void if any of these warnings are disregarded. 1.4.2 CAUTIONS: • Federal law (United States of America) restricts this...

• 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 of 700 hPA to 1,060 hPa. • Storage environmental ambient temperature 14°F to140°F (-10°C to 60°C). • Storage environmental relative humidity 10% to 75%. Th re are no user serviceable components in the Smoke Shark II Smoke Evacuation System(s). Refer service to qualified service personnel. Use only with the power cord provided and always plug into a grounded outlet. Smoke Shark II Operator

DESCRIPTION/MEANING WARNING: DANGEROUS VOLTAGE TYPE CF APPLIED PART. PROTECTION AGAINST INGRESS OF WATER AS DETAILED IN IEC 60529. ALTERNATING CURRENT. PROTECTIVE EARTH, (GROUND). EQUIPOTENTIALITY. DENOTES THE DATE THE EQUIPMENT WAS MANUFACTURED. MANUFACTURER NON-IONIZING RADIATION MANDATORY: REFER TO INSTRUCTION MANUAL/GUIDE DANGER- EXPLOSION RISK IF USED WITH FLAMMABLE ANESTHETICS. DO NOT USE IF PACKAGING IS DAMAGED OR OPENED. DO NOT RESTERILIZE DO NOT REUSE. THIS IS A SINGLE USE DEVICE. STERILE RADIATION STERILE ETHYLENE OXIDE OPERATING TEMPERATURE LATEX FREE Smoke Shark II Operator’s Manual:...

Figure 1 Unit Control Panel SYSTEM MOTOR POWER BUTTON SUCTION SPEED BUTTON: PRESS TO CYCLE THROUGH HIGH, MEDIUM AND LOW SPEEDS MOTOR ON LED INDICATOR STANDBY MODE LED INDICATOR SERVICE/TROUBLESHOOTING REQUIRED LED INDICATOR MOTOR SPEED LED INDICATORS: Upper Light: HIGH SPEED Center Light: MEDIUM SPEED Lower Light: LOW SPEED CURRENT FILTER LIFE INDICATOR: AS LIGHTS MOVE FROM GREEN TO RED, FILTER LIFE DEPLEATS. REPLACE FILTER WHEN RED. Smoke Shark II Operator’s Manual: Page 10