Smoke Shark™ III Surgical Smoke Evacuator Operator’s Manual www.symmetrysurgical.com +1 615.964.5532 (International) 800.251.
TABLE OF CONTENTS Section Title Page — DIAGRAM / CONTENTS 3 — GLOSSARY 4 1.0 1.1 1.2 1.3 1.4 DESCRIPTION/ INTRODUCTION Introduction Inspection Operational Information Cautions and Warnings 5 2.0 2.1 2.2 2.3 2.4 2.5 2.6 OPERATING INSTRUCTIONS Control Panel Set-up and Operation Filter Instructions Automatic Activation Device Instructions Performance References Electromagnetic Compatibility Information per IEC 60601-1-2 9 3.0 3.1 3.2 3.3 3.
DIAGRAM / CONTENTS Filter Life Indicator (LED) Motor On Indicator (LED) Suction On / Standby Button One-Port Filter with Hidden Male Port CONTROL PANEL Service Indicator (LED) Power Off / On Button Automatic Activation Device Port Standby Indicator (LED) Model # SE03-120 FRONT Bovie® products are exclusively distributed by: Symmetry Surgical Inc.
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 filter 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 filtration.
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.
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.
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.
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.
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.
OPERATING INSTRUCTIONS: SECTION 2.0 3. 4. 5. 6. 7. 8. 9. Install the filter (see filter installation instructions, section 2.3). 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. Ensure that any smoke evacuation capture accessory is fully installed in the filter port.
OPERATING INSTRUCTIONS: SECTION 2.0 2.4 Automatic Activation Device Instructions Clean with alcohol. 1 2 3 4 0 sec. – 10 sec. Delay. 5 6 7 8 2.5 Performance References* Performance Model Name/ Number Maximum Flow Setting (LPM-U.S.) Standard Hose I.D.
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 specified below. The customer or user of the Bovie® Smoke Shark Surgical Smoke Evacuator should ensure that it is used in such an environment.
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 specified below. The customer or user of the Bovie® Smoke Shark Surgical Smoke Evacuator should ensure that it is used in such an environment.
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 specified below. The customer or user of the Bovie® Smoke Shark Surgical Smoke Evacuator should ensure that it is used in such an environment.
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.
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.
CUSTOMER SERVICE: SECTION 4.0 Report complaints involving this device to bovie.complaint@symmetrysurgical.com 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.
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.
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.
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 specified in this manual has been performed using replacement parts approved by Symmetry Surgical, Inc.
