WALLACH
Biovac Instructions for Use Rev A June 2014
Instructions for Use
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Biovac Smoke Evacuator REF 909070 (120VAC) and 909070-05W (220VAC) This device complies with the EC Medical Device Directive (93/42/EEC) The Wallach BIOVAC Smoke Evacuator is a simple-to-operate electrical device designed to remove smoke particulate (smoke plume) generated as a by-product of certain medical procedures, such as electrosurgery and electrocautery. It is intended for use in short term procedures performed in a physician’s office.
WARNINGS READ ALL SAFETY INFORMATION AND INSTRUCTIONS BEFORE USING THIS PRODUCT! TYPE BF EQUIPMENT • Do not use this device in the presence of potentially explosive anesthetic gases. • Always use a three-prong, grounded electrical outlet to prevent the possibility of electrical shock.
CAUTIONS •
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U.S. Federal law restricts this device to sale by or on the order of a physician. Do not use an electrical extension cord. However, a UL-approved power strip (such as those used on accessory carts) of sufficient current rating is acceptable. The STERILE Disposable Smoke Evacuator Tubing is for single patient use only. Due to possible cross contamination, it is to be used for one patient, then discarded per local, state, or federal regulations regarding medical waste disposal. The maximum allowable continued use of a single Filter Assembly is 30 minutes. Filter efficiency and effectiveness are dramatically decreased, rendering it ineffective, if used for a longer period. Unplug the unit before changing the fuse. Do not allow fluids of any kind to enter the device, either from spills on the cabinet, or through the vacuum hose. This may create an electrical hazard.
BIOVAC SMOKE EVACUATOR COMPONENTS The Wallach BIOVAC Smoke Evacuator consists of two components: a) the Motor Cabinet, with its electric motor and controls, and b) the Smoke Plume Filter Assembly and a Sterile single use Disposable Smoke Evacuation Tubing.
MOTOR CABINET The Motor Cabinet contains a high power motor/blower which is controlled by two switches: a) the POWER ON-OFF switch and b) the Air Flow Control Switch (labeled SUCTION ADJUST), which adjusts the amount of air being moved. There are no electrical user-serviceable components within the cabinet. NOTE: Electrical fuses are located on the rear of the cabinet. Prior to your first use, connect a Filter Assembly and Disposable Smoke Evacuator Tubing. Operate the Smoke Evacuator through the range of vacuum available. The sound level increases as the vacuum range is increased. Although the cabinet is sound-insulated, it is the nature of high efficiency blower motors to produce elevated sound levels. Some experimentation will lead to the correct setting.
IMLP001-IFU • Rev. A • 6/14
Wallach® Surgical Devices
ADJUSTABLE HANDLE The Wallach BIOVAC is shipped with the handle detached. To attach the handle, insert it with spring-loaded pins facing back and engage bottom pins. To raise or lower handle, depress the pins. Precaution: Be sure spring pins are engaged before attempting to lift by handle to avoid detachment.
FILTER ASSEMBLY The non-sterile Filter Assembly utilizes two filter devices to clean the collected air. Within the length of the four-foot hose is a smoke scrubbing, odor removing material that will compress as the Smoke Evacuator is operated. This compression will eventually restrict the flow of air in the tube, thus limiting the amount of time that the Smoke Evacuator can be in continuous use (using the same Filter Assembly). The expected maximum operating time limit for the filter is 30 minutes, which far exceeds the typical time needed for one electrocautery or electrosurgery procedure. Should the device continue running beyond this operational range, the unit may become warm to the touch and the filter will become ineffective. The second filter element, a viral, bacterial, particulate filter, is positioned in the filter assembly at the connecting end of the hose (connecting to the Motor Console). It efficiently removes potentially harmful microbes as small as .02 microns.
OPERATING INSTRUCTIONS 1) Set the unit in an upright position on a solid structure with a smooth level surface. 2) Be certain the Wallach BIOVAC Smoke Evacuator is turned OFF. electrical receptacle.
Now plug the cord into a grounded
3) Open a fresh Filter Assembly package. Attach the square filter housing of the hose assembly to the smoke collection port in the center of the top cover. Attach the sterilized disposable filter tubing. 4) Attach the distal end of the tubing to the speculum. 5) Turn the unit ON by depressing the POWER switch, and regulate the SUCTION ADJUST knob control to suit the condition, keeping in mind that the sound level increases as the vacuum increases. Test the unit prior to each patient use to insure that the BIOVAC Smoke Evacuator is drawing air, and to acquaint your patient with the sound of the motor. 6) When the procedure is complete, turn off the unit; remove the Disposable Tubing. NOTE: Do not operate this device without a Filter Assembly in place.
ACCESSORIES DESCRIPTION
RECOMMENDED REPLACEMENT
STERILE Disposable Tubing
Before every procedure
Single Filter Assembly
After 30 minutes of continuous use
IMLP001-IFU • Rev. A • 6/14
Wallach® Surgical Devices
TROUBLE SHOOTING/FUNCTIONAL TESTING PROBLEM Motor does not run
POSSIBLE CAUSE 1. 2. 3. 4.
A. Unit not plugged in B. Receptacle not active ON switch not “ON” Fuse blown/defective Defective motor
CORRECTIVE ACTION 1. 2. 3. 4.
A. Plug in power cord B. Activate receptacle Activate switch to “1” Replace Return to factory
SPECIFICATIONS Electrical requirements:
120VAC, 50/60 Hz, 7.0A
220VAC, 50/60 Hz,5.0A
Electrical Fuses:
Two T10AL250V
Two 6.3A, 250V, Slow Blow, 5 x 20 mm (littelfuse 21806.3)
Power Cord Length Power Plug
2.4 m Hospital Grade
Sound Level From One Meter:
65 to 75 DBA
Air Flow Range Filtration:
4.5 to 7.0 m3/h 99.99% Effective to .02 Micron
Filter/Tubing/Straw Length
3.35 m 57.2 cm x 25.4 cm x 25.4 cm (including handle) Approximately 11.4 kg USA
Dimensions: Weight: Country of Origin
MAINTENANCE After each use, the unit must be cleaned and disinfected. To sanitize the unit, wipe down with a disinfectant.
WARRANTY The Wallach BIOVAC Smoke Evacuator is supported by a one-year warranty from date of purchase covering any failure of the device due to defective workmanship or components, when used in compliance with the product’s intended use. The warranty remains valid within the time period, provided only Wallach supplied filter sets and components are used with the device. If repair is attempted outside the factory, the warranty will be considered void.
SERVICE/REPAIR Only Wallach Surgical Devices is authorized to service or repair this unit. There are no user-serviceable components within the housing. If repair is attempted outside the factory, the warranty will be considered void. Wallach Surgical Devices is not responsible for any injury resulting from repairs made by other individuals or organizations not certified by Wallach Surgical Devices. If a repair is needed, carefully package the Integration Unit in a protective carton. Include a note explaining the problem. Equipment must be sanitized before it is returned. Items that are not sanitized will be returned to the customer freight collect. All shipments must be made via pre-paid parcel post or U.S. Mail. C.O.D. packages will not be accepted. Return carton to the attention of the Repair Dept. at: Wallach® Surgical Devices 95 Corporate Drive Trumbull, CT 06611 USA Phone: (203) 799-2000 800-243-2463 Fax: (203) 799-2002 Web: www.wallachsurgical.com
IMLP001-IFU • Rev. A • 6/14
Wallach® Surgical Devices
EXPLANATION OF SYMBOLS REF
Reorder number
SN
Serial number Shock hazard warning Caution Consult instructions for use TYPE BF Applied Part = Type of equipment is a type B equipment with an F type applied part. Type B equipment is a piece of equipment providing a particular degree of protection against electric shock, particularly regarding: -Allowable leakage current -Reliability of the protective earth connection Type F = isolated (floating) applied part isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1.1 times the highest rated mains voltage is applied between the applied part and earth. Alternating Current = AC current
Rx Only U.S. Federal law restricts this device to sale by or on the order of a licensed physician. Manufacturer Product conforms to the Medical Device Directive 93/42/EEC
EC REP
Authorized Representative in the European Community:
EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands
Wallach® is a registered trademark of CooperSurgical, Inc. © 2014 CooperSurgical, Inc. IMLP001-IFU • Rev. A • 6/14
CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA
Wallach® Surgical Devices