USER’S GUIDE User’s Guide • Bovie Smoke Shark ™ Surgical Smoke Evacuator 1
TABLE OF CONTENTS Introduction .................................................................................................................3 Inspection ....................................................................................................................3 Operational Information ...............................................................................................4 Cautions and Warnings ..............................................................................................
INTRODUCTION The Bovie® Smoke Evacuator System (SE01) is designed to remove smoke and noxious odors produced by surgical smoke during laser and electrosurgical procedures. The smoke evacuator system has been designed with a high-suction, high-flow rate centrifugal action pump. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the SF18 filter where the surgical smoke is processed by a series of filters.
OPERATIONAL INFORMATION The operational information contained in this section is intended for the customer review of regulatory issues. The information pertains to the use of the products both domestically and internationally: 1. The smoke evacuator system complies with IEC601.1 electrical specifications in the following systems: 120V/60Hz, l00V/50Hz, 220V/50Hz, 240V/50Hz. 2. The smoke evacuator system has a classification under the UL2601-1, Clause 5.1 of: CLASS 1 Equipment. 3.
CAUTIONS AND WARNINGS Please note that all Cautions and Warnings should be read and understood before any use of this equipment. This smoke evacuation system should only be operated by personnel who have been properly trained in its operation. WARNINGS: The 18-hour filter is completely disposable. Please handle these disposable filters according to your local codes or regulations and hospital policy. These filters may be disposed of or incinerated, whichever is appropriate for your institution.
OPERATING INSTRUCTIONS System Controls: The electronic system controls on the smoke evacuator system are easy to understand and simple to use. The membrane control panel contains the soft power ON/OFF switch, Suction Control adjustment, Filter-Life Remaining indicator, and Service required indicator. (see figure 1) Figure 1 - Control Key Pad NOTICE: Please be sure to read all instructions before installing accessories or operating this equipment.
Footswitch/Remote Switch Activator (Membrane Control Panel): A footswitch or a remote switch activator may be added to any system by simply plugging in an activation accessory into the appropriate jack on the side of the unit. When the footswitch is plugged in, the unit may be turned on or off by depressing the footswitch pedal once for each operation. For footswitching operation, the power switch on the membrane control panel should be in the ON position.
Filter Removal Instructions: 1. After the SF18 filter has been exhausted and requires changing, turn the smoke evacuation system off and disconnect the unit’s electrical cord and any accessory tubing attached to the filter. 2. Pull the SF18 filter from the smoke evacuation system and dispose of in accordance with hospital policy. The SF18 filter may be disposed of or incinerated. 3. Clean the unit with appropriate germicide prior to re-use.
SPECIFICATIONS FOR SMOKE EVACUATOR SYSTEM Configurations Portable or Tabletop 18-hour filters, single or double ports 7/8" (22mm) and/or 1 1/4" (32mm) 3-Stage filtration in one casing (ULPA, Carbon) Filters particle size, μm ULPA, VLSI Grade 0.1 to 0.2 @ 99.999% efficiency Filter life 18 hours Max. Flow Setting SCFM (Std. cubic ft./minute) Tubing Size 13/8" – NA, 1 1/4" – 38, 7/8" – 28 SLPM (Std.
MAINTENANCE General Maintenance Information: This section contains information for ordinary upkeep of the smoke evacuator 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.
CUSTOMER SERVICE 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 evacuator system. Step 2: Call Customer Service at the toll free or local number listed and describe the problem. Step 3: If the problem cannot be resolved over the phone and the equipment must be returned for repair, you must obtain a “Returned Goods Authorization” (R.G.A.) number from Customer Service before returning the system.
LIMITED WARRANTY For a period of two (2) years following the date of delivery, Bovie Medical Corporation warrants the smoke evacuator system against any defects in material or workmanship. This warranty is void if the product is used in a manner or for purposes other than intended. Warranty: Bovie Medical Corporation warrants that the filter system shall be free from defects in material and workmanship.
SYMBOL KEY Symbol Description / Meaning DANGER: Risk of explosion if used in the presence of flammable anesthetics. CAUTION: Grounding reliability can only be achieved when the equipment is connected to a receptacle marked “Hospital Grade” or “Hospital Only”. CAUTION: Electric shock hazard. Do not remove cover. Refer servicing to qualified service personnel. Before connecting, read instructions. Type CF equipment. IPX1 Protect against dripping water. Alternating current.
14 Bovie Medical Corporation
2012-07-27