VisiClear ™ Surgical Smoke Plume Evacuator Operator’s Manual © 2014 BUFFALO FILTER® 5900 Genesee Street Lancaster, New York 14086, USA (716) 835-7000 or (716) 835-3414 fax www.buffalofilter.com Customer Service: 800-343-2324 (U.S.
For a period of three (3) years following the date of delivery, BUFFALO FILTER® warrants the VisiClear™ against any defects in material or workmanship. BUFFALO FILTER® will repair or replace (at BUFFALO FILTER’s option) the same without charge, provided that routine maintenance as specified in this manual has been performed using replacement parts approved by BUFFALO FILTER®. This warranty is void if the product is used in a manner or for purposes other than intended.
Table of Contents and List of Illustrations Title SYSTEM DESCRIPTION Introduction Inspection Operational Information Cautions and Warnings Page 4 2.0 2.1 2.2 2.3 2.4 OPERATING INSTRUCTIONS System Controls VisiClear™ Filter Instructions Set-up and Operation Specifications 10 3.0 3.1 3.2 3.3 3.4 MAINTENANCE General Maintenance Information Cleaning Periodic Inspection Troubleshooting 25 4.0 4.1 4.2 CUSTOMER SERVICE Equipment Return Ordering Information 28 5.
System Description Section 1.0 1.1 Introduction Indications for use for the VisiClear™ Surgical Smoke Plume Evacuator include: To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures. The VisiClear™ Surgical Smoke Plume Evacuators have been designed with a vacuum motor.
Standard Accessories: • Operator’s Manual • Power Cord • Pneumatic Footswitch Please contact BUFFALO FILTER® Customer Service to purchase the following accessories: • Replacement Filters • EZLink™ Automatic 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 issues.
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 the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
1.4.1 WARNINGS: • Read this manual thoroughly and be familiar with its contents prior to using this equipment. • This equipment is intended for use by trained healthcare professionals only. • This equipment 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 VisiClear™ or shielding the location. • Test this equipment prior to a surgical procedure.
• Changes or modifications not expressly approved by BUFFALO FILTER® 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 device to be used by, or on the order of a physician. • The VisiClear™ motor generates heat during operation.
Symbol Description / Meaning CAUTION TYPE CF APPLIED PART IPX1 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 CONSULT INSTRUCTIONS AUTOMATIC ACTIVATION DEVICE FOOTSWITCH Buffalo Filter® VisiClear™ Operator’s Manual 9
Operating Instructions Section 2.0 2.1 System Controls The electronic system controls on the VisiClear™ Surgical Smoke Plume Evacuator(s) are easy to understand and simple to use. To power up the machine, connect the supplied power cord to a grounded outlet and the appliance inlet on the back of the smoke evacuation system. Once power has been applied, the unit’s touch screen will illuminate and a start up process will begin. This will take about 20 seconds to complete.
During an open procedure in which a smoke plume evacuation hose will be utilized, please select the Open Tubing Button. When using either an attachment to your electrosurgical pencil or an integrated smoke plume evacuation pencil such as Buffalo Filter’s PlumePen™, please select the Electrosurgical/Diathermy Mode Button. Finally, when attaching to a surgical cannula during laparoscopic procedures, please select the Laparoscopic Button.
Figure 4. FOOTSWITCH / EZLINK AUTOMATIC ACTIVATION DEVICE The VisiClear™ Surgical Smoke Plume Evacuator also comes equipped with a pneumatic footswitch. A footswitch or an EZLink Automatic Activation Device may be added to any system by simply plugging in a BUFFALO FILTER® activation accessory into the appropriate jack on either the front (footswitch) or back (EZLink) panel of the unit.
Figure 5. Filter life can be displayed in both hours and minutes or as a percentage using the Settings button located in the lower left section of the touch screen. See Figures 6 and 7. Figure 6. Figure 7. When the maximum filter life is consumed, the following warning screen will appear indicating that a filter replacement is needed. After inserting a new VisiClear™ Filter, press the green check mark to clear the warning and resume normal operation.
Figure 8. VISICLEAR™ OCCLUSION ALARM: The VisiClear™ Surgical Smoke Plume Evacuator is equipped with an occlusion alarm for certain system settings. The default setup for the device has this option disabled. If you wish to utilize the occlusion alarm, during initial start-up please enable by pressing the alarm icon located on the top left of the screen until the red X is not visible. See Figure 9. Figure 9.
The unit will continue to cycle the suction, checking to see if the obstruction has been cleared. If the obstruction is cleared, the alarm will automatically turn off and the system will resume normal operation. The user also has the option of disabling the alarm during continued use. If the obstruction is not removed or you wish to disable this feature, you may disable the alarm by pressing the following button on the alarm screen until the red X appears on the occlusion symbol as shown. See Figure 11.
If the obstruction is not removed or you wish to disable this feature, you may disable the alarm by pressing the following button on the alarm screen until the red X appears on the occlusion symbol as shown. See Figure 14. Figure 14. Once the alarm is disabled, please press the green checkmark to remove the warning screen and resume normal operation. LAPAROSCOPIC MODE: The occlusion alarm is not functional in the Laparoscopic mode on the VisiClear™ system and will default off in this mode.
If this message occurs, it is appropriate to notify BioMed or contact BUFFALO FILTER® to arrange service of the VisiClear™ system. The system will continue to operate by pressing the check mark button unless a fatal condition has taken place with the motor. If the system does not respond after the check mark button is pressed, contact BioMed or BUFFALO FILTER® to arrange service of the VisiClear™ system.
You may also adjust the brightness of your touch screen display by pressing the button that contains a sun illustration. See Figure 20. Figure 20. Once you press this button, the screen below will appear and you may use the negative button to decrease brightness or positive button to increase brightness. See Figure 21. Figure 21.
Figure 23. FUSES (circuit board) Two 10 AMP fuses (8 AMP for 220/240 VisiClear™ Systems) are located on the circuit board within the housing of the system. It electrically protects both the systems and the operator from damage or injury. If the system is overheated or if there is an electrical surge in the electrical system, fuses will break and the system will not operate. When the Service light illuminates, please contact BUFFALO FILTER® Customer Service for system service instructions. 2.
2. Insert the VisiClear™ Filter into filter receptacle. Be sure that the filter is seated completely against the bottom of the filter chamber and clip is fully engaged. WARNING: This device is not intended for evacuation of fluid. If fluid is expected to be aspirated using the VisiClear™ Filter or the BUFFALO FILTER® VisiClear™ system, fluid collection devices must be installed with the vacuum hose assembly. Failure to install a fluid collection device may cause filter blockage and/or electrical damage.
2.4 Performance References* Performance Model Number VisiClear™ Maximum Flow Setting (CFM-U.S.) Standard Hose I.D. 7/8” 30 CFM ** 3/8” 4.6 CFM 1/4” 1.9 CFM Standard Hose I.D. 22 mm 850 LPM ** 9.5 mm 130 LPM 6.4 mm 54 LPM Dimensions (H x W x D ) inches 7 x 14 x 16 Dimensions (H x W x D ) centimeters 17.8 x 35.6 x 40.6 Weight Noise Level, dBA lbs (kg) 17 lbs (7.
2.5 Electromagnetic Compatibility Information per IEC60601-1-2 Table 1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Surgical Smoke Plume Evacuator model VisiClear™ is intended for use in the electromagnetic environment specified below. The customer or user of the VisiClear™ should assure that it is used in such an environment. Emissions Test RF Emissions Compliance Group 1 The VisiClear™ uses RF energy only for its internal function.
Table 2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The model VisiClear™ is intended for use in the electromagnetic environment specified below. The customer or user of the model VisiClear™ should assure that it is used in such an environment.
Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The model VisiClear™ is intended for use in the electromagnetic environment specified below. The customer or user of the model VisiClear™ should assure that it is used in such an environment.
Maintenance Section 3.0 Table 4 Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Model @ 3 Vrms The model VisiClear™ is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
3.1 General Maintenance Information This section contains information for ordinary upkeep of the BUFFALO FILTER® VisiClear™. 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 prior to cleaning. Wipe unit with a damp cloth containing mild disinfectant solution.
3.4 Troubleshooting the System – see below. PROBLEM POTENTIAL CAUSE CORRECTIVE ACTION 1. Smoke Evacuation System is ON but suction is minimal or none. 1. Filter is not seated completely. 1. Re-install VisiClear™ Filter, press firmly into place and fully engage clip. 2. Filter is clogged. 2. Replace filter with a genuine Buffalo Filter VisiClear™ Filter. 3. Vacuum hose or tube is clogged. 4. Motor/blower is obstructed. 2.
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 VisiClear™ Surgical Smoke Plume Evacuator. Step 2: Call Customer Service at the toll free or local number listed and describe the problem.
5.1 Specifications Specifications are subject to change without notice. SHIPMENT OF ORDER: BUFFALO FILTER® will try to accommodate individual customer requests for shipping method. BUFFALO FILTER® 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 5.2 Warranty BUFFALO FILTER® warrants that the filter system manufactured by BUFFALO FILTER® shall be free from defects in material and workmanship.
