Operator’s Manual © 2012 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.
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.
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 OPERATING INSTRUCTIONS 11 2.1 System Controls 2.2 Bovie® SF35 Filter Instructions 2.3 Set-up and Operation 2.4 Specifications 3.0 MAINTENANCE 21 General Maintenance Information 3.1 3.2 Cleaning 3.3 Periodic Inspection 3.4 Troubleshooting 4.0 CUSTOMER SERVICE 22 4.
1.1 Introduction 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.
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.
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.
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.
• 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 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%. There are no user serviceable components in the Smoke Shark II Smoke Evacuation System(s). Refer service to qualified service personnel.
SYMBOL DESCRIPTION/MEANING WARNING: DANGEROUS VOLTAGE. WARNING. 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. DENOTES THE MANUFACTURER OF THE DEVICE. NON-IONIZING RADIATION. MANDATORY: REFER TO INSTRUCTION MANUAL/GUIDE. DO NOT RESTERILIZE. SINGLE USE ONLY. DO NOT USE IF PACKAGE IS DAMAGED.
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.
Operating Instructions Section 2.0 2.1 System Controls The electronic system controls on the Smoke Shark II Smoke Evacuation System(s) are easy to understand and simple to use. The membrane control panel contains the suction on/off switch, suction power adjustment, filter life indicator, and service indicator light. See Figure 1. Note: Please be sure to read all instructions before installing accessories or operating this equipment. Failure to do so may result in damage to the unit and/or personal injury.
• FILTER LIFE INDICATOR (Membrane Control Panel) The filter life indicator on the membrane control panel provides a visual indication of the status of the life of the filter in use. The filter life indicator for the Bovie® Smoke Shark II Smoke Evacuation System will automatically adjust according to the flow setting selected.
2.2 Bovie® SF35 Filter Instructions Bovie® P/N: Configuration: Bovie® SF35 Filter - Multi Port Filter: Filter(s): Particle Size, µm: Filter Life: Filter Life Indicator: SF35 Portable or tabletop 4-Stage Filtration In One Casing, (Pre-Filter, ULPA, Carbon, Post-Filter) ULPA 0.1 to 0.2 Microns At 99.999% Efficiency Automatic Factory Set Filter Sensor Timed Replacement Note: Before installing or removing any filter, be sure that the system is turned off.
2.3 Set-Up and Operation The operation of the Smoke Shark II Smoke Evacuation System is as follows: 1. Install the Bovie® SF35 Filter. 2. Attach unit power cord to the receptacle on the rear of the system. Plug the pronged power cord into an appropriate grounded power outlet. Route power cord in such a way as to minimize potential trip hazard by users or patients or pinch hazard that could cause electric shock. 3.
2.4 Performance References* PERFORMANCE Smoke Shark II Model Number Maximum Flow Setting Standard Hose I. D. (CFM) 7/8” 25 CFM 3/8” 4.5 CFM 1/4” 2 CFM Maximum Flow Setting (lfm-Metric) Standard Hose I. D. (LPM) 22mm 708 LPM 9.5mm 130 LPM 6.4mm 57 LPM Dimensions (H x W x D) inches 6 x 11 x 15.5 Dimensions (H x W x D) centimeters 15.2 x 27.9 x 39.4 Weight lbs (kg.) 10 lbs / (4.3 kgs) Noise Level, dBA MAXIMUM 55.
2.5 Electromagnetic Compatibility Information per IEC60601-1-2 Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions The Smoke Evacuation System model Smoke Shark II is intended for use in the electromagnetic environment specified below. The customer or user of the Smoke Shark II should assure that it is used in such an environment.
The model Smoke Shark II is intended for use in the electromagnet environment specified below. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Smoke Shark II requires continued operation during power mains interruptions, it is recommended that the Smoke Shark II be powered by an uninterruptible power supply or battery.
Bovie® is a registered trade mark of Bovie Medical Corporation Smoke Shark II Operator’s Manual: Page 18
The model Smoke Shark II is intended for use in the electromagnet environment specified below. The customer or end user of the Smoke Shark II should assure that it us used in such an environment. Smoke Shark II Smoke Shark II.
The Smoke Shark II is intended for use in an electromagnetic environment in which radiated RF distubances are controlled. The customer or the user of the Smoke Shark II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Smoke Shark II as reccomended below, according to the maximum output power of the communications equipment.
Maintenance Section 3.0 3.1 General Maintenance Information This section contains information for ordinary upkeep of the Bovie® Smoke Shark II Smoke Evacuation System. While the system has been designed and manufactured to high industry standards, it is recommended that periodic inspection and performance testing be performed by a qualified Biomedical Technician to ensure continued safe and effective operation. 3.2 Cleaning Unplug Unit.
Customer Service Section 4.0 4.1 Equipment Return For the quickest response to your service needs, please follow these procedures: Step 1: Write down model and the serial number of the Smoke Shark II Smoke Evacuation System. Step 2: Call Customer Service at the toll free or local number listed and describe the problem.
Terms & Warranty Section 5.0 SPECIFICATIONS: WARRANTY*: Specifications are subject to change without notice. Bovie® warrants that the filter system manufactured by Bovie® shall be free from defects in material and workmanship.
© 2012 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.
