PlumeSafe TURBO Auto-Sense Operators Manual Ver C

Limited Warranty For a period of three (3) years following the date of delivery, BUFFALO FILTER warrants the PlumeSafe TURBO Auto-Sense 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.

© 2005 BUFFALO FILTER® 595 Commerce Drive Buffalo, New York USA 14228 www.buffalofilter.com Division of Medtek Devices, Inc. Customer Service: 800-343-2324 (U.S. Only) (716) 835-7000 The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed errata pages (if any).

Manual Number PSWT-AS Ver. C 7/2005 ®

PlumeSafe TURBO Auto-Sense

™

Classified by Underwriters Laboratories, Inc. with respect to electric shock, fire and mechanical hazards only in accordance with UL2601-1 9D93

9D93

Table of Contents Page 1.0 Introduction... 1 2.0 Inspection... 1 3.0 Operational Information... 1 4.0 Warnings and Cautions... 1- 2 5.0 Operating Instructions... 2-4 - Key Pad Diagram - Power ON/ OFF - Motor ON/ OFF - Suction Control - TURBO Mode - Filter Life Remaining - Footswitch - Remote Switch Activator (RSA) - Circuit Fuses - Service 6.0 Maintenance... 5 - Cleaning - Periodic Inspection - Troubleshooting 7.0 Specifications... 6 8.0 Ordering Information... 6 9.0 Equipment Return... 7 10.0 Terms... 8 - Confidential Information - Consequential Damages/ Limits of Liability - Entire Agreement - Jurisdiction - Shipment of Order 11.0 Warranty... 8

1.0 Introduction ®

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The BUFFALO FILTER PlumeSafe TURBO Auto-Sense Smoke Evacuation System is designed to remove smoke and aerosols and noxious odors produced during, but not limited to, laser and electrosurgical procedures. The PlumeSafe TURBO Auto-Sense Smoke Evacuation System has been designed with a high suction, high flow rate centrifugal action pump. The ultra quiet motor is used to draw the smoke ® plume from the surgical site through the vacuum tubing/hose into the ViroSafe filter where the surgical smoke is processed by 4 stages of filtration. Built into a single housing, this disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes and is totally filter life automated via RFID technology. 2.0 Inspection The BUFFALO FILTER PlumeSafe TURBO-AS Smoke Evacuation System has been thoroughly tested and inspected before shipment from the factory. Please check the unit before setup to insure that no damage has occurred in transit. If damage is evident, please contact BUFFALO FILTER customer service at 1-800-343-2324 (USA) or 1-716-835-7000 (international). 3.0 Operational Information The BUFFALO FILTER PlumeSafe TURBO-AS Smoke Evacuation System complies with UL/IEC 60601.1 electrical standard in the following systems: ! 100v- 132v 50/60 Hz ! 220v- 240v 50/60 Hz 4.0 Warnings and Cautions 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 Buffalo Filter ViroSafe Filters are completely disposable. Please handle these disposable filters according to your local codes, regulations, and institution policy. ! This device is not intended for evacuation of fluid. If fluid is expected to be aspirated to the ViroSafe Filter, fluid collection devices must be installed with the vacuum hose assembly. Failure to install a fluid collection device could cause filter blockage and electrical damage. ! DO NOT OPERATE THIS DEVICE IN THE PRESENCE OF EXPLOSIVE GASES. EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. ! REFER ROUTINE SERVICING TO QUALIFIED BIOMEDICAL TECHNICAL PERSONNEL. ! There are no user serviceable components in the PlumeSafe TURBO Auto-Sense Smoke Evacuation System. ! Use only with the power cord provided and always plug into a grounded outlet. 1

4.0 Warnings and Cautions, Continued SYMBOL

DESCRIPTION/MEANING

IPX1

Medical Equipment with respect to electrical shock, fire and mechanical hazards only. In accordance with UL 2601-CAN/CSA C22.2 No.601.1

Cautions: ! Do not block either the tubing or the filter. If either becomes occluded or significantly restricted, the motor/blower may overheat and cause the unit to become inoperative. ! Attempting to use any other filter or accessory not supplied by Buffalo Filter may cause damage and/or cause the system to be inoperable and will void the warranty. ! Care must be exercised in the installation of hoses, adapters, suction canisters. Failure to follow the procedures outlined in this manual may result in over heating of the motor and may void the unit warranty. 5.0 Operating Instructions The Turbo Auto-Sense LCD control display is user-friendly and completely interactive, allowing for easy to understand use (as displayed on the LCD screen). Key Pad Diagram

LCD Panel Increase Suction RFID Intelligence Inside

Suction Motor ON/ OFF TURBO Mode Button Decrease Suction

FIGURE 1 2

5.0 Operating Instructions, Continued The following items are important for the operation of your system. POWER ON/OFF The main power switch is located on the rear panel of your smoke evacuator. This switch completely enables and disables the main power. When the unit is powered on the following LCD screen will appear.

BUFFALO FILTER

After inserting a filter a screen will flash for a few seconds to indicate filter type and original life. BUFFALO FILTER

INSERT VIROSAFE FILTER

VIROSAFE-XLL 18 HOUR FILTER

Next, the standard screen will appear which displays information regarding the unit’s current activity. Virosafe-XLL HR-MN Time Remaining 1 7-3 1 Suction Setting 0% M o d e - N O R M L M o t o r- O F F

MOTOR ON/OFF The Motor ON/OFF button is located on the LCD key pad (Figure 1). This button turns the motor (for suction) on and off. SUCTION CONTROL The amount of suction may be adjusted using the UP or DOWN arrow buttons located on the key pad (Figure 1). Suction may be adjusted up or down by 10% increments. It is recommended that you select the lowest suction setting that effectively clears the operative field of surgical smoke. TURBO MODE The TURBO button is located on the key pad (Figure 1). The amount of suction is significantly increased when this button is pressed. To return to NORMAL mode, press the TURBO button again. FILTER LIFE REMAINING The exact number of hours and minutes remaining on the ViroSafe filter (in use) are displayed on the LCD screen. When the filter’s life is consumed, time remaining will indicate that there are 0 hours and 0 minutes remaining. This line will continually flash. When the filter life reaches this point, a new filter with time remaining should be inserted; however, the suction will still work. When the unit’s main power is turned off or the system is left idle for more than 6 hours, a new filter or a filter with remaining filter life MUST be inserted into the filter basket to allow the unit’s suction to turn back on. When the filter’s life is exhausted the LCD screen will flash “REPLACE FILTER.”

Virosafe-XLL HR-MN REPLACE FILTER 0 0-0 0 Suction Setting 100% M o d e - N O R M L M o t o r- O N

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5.0 Operating Instructions, Continued FOOTSWITCH A pneumatic footswitch is provided. To activate the footswitch, simply plug the footswitch tubing into the jack ( ) on the rear panel. The suction can now be switched ON/OFF by depressing the footswitch. REMOTE SWITCH ACTIVATOR (RSA1002) For directions on using the Remote Switch Activator, see instructions accompanying the RSA1002. CIRCUIT FUSES Two 10 amp circuit fuses (8 amp for International systems) are located on the rear panel within the power entry module. These circuit fuses protect both the system and the operator from damage or injury. SERVICE When a service message appears, please contact Buffalo Filter Customer Service for instructions. Below are some examples of service screens that may appear. If this screen appears the system may be in need of service for the motor. Call Buffalo Filter.

Brush Hours=500 IF OVER 500HRS CALL: 1-800-343-2324 1-716-835-7000

If this screen appears there may be a problem with your system or filter. Call Buffalo Filter.

FILTER I.D. ERROR! CALL FOR SERVICE 1-800-343-2324 1-716-835-7000

SETTING THE DEFAULT LANGUAGE 1. Turn the mains power on without filter inserted. 2. Scroll through languages using suction control arrow buttons and select a language by pressing motor button. 3. Smoke Evacuator will use this language as the default language. 4. To change the default language, remove filter and press motor on and turbo button simultaneously. 5. Repeat step 2.

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6.0 Maintenance CLEANING The exterior of the system may be cleaned by unplugging the unit, wiping it with a cloth that has been dampened (not dripping) with a mild detergent or surface disinfectant. PERIODIC INSPECTION The PlumeSafe Smoke Evacuation System should be visually inspected at least once a year. This inspection should include: ! Inspecting for damage to power cord ! Inspecting for damage to power plug ! Checking the tightness of power plug ! Ensuring there is proper mating, cleanliness, and absence of damage to the filter inlet ! Ensuring there isn’t any obvious external or internal damage to the system TROUBLESHOOTING THE SYSTEM The following chart can be used to help troubleshoot typical problems. PROBLEM

POTENTIAL CAUSE

CORRECTIVE ACTION

1. System does not appear to have any power (no lights).

1. Not plugged into electrical outlet or power entry module. 2. Fuses are blown. 3. Main power switch is in OFF position. 4. Electronic system failure.

1. Check power outlet and ensure connection to rear panel of machine. 2. Replace fuses located within the power entry module. 3. Check main power switch on rear panel of system to ensure that it is in the ON ( I ) position. 4. Call Buffalo Filter’s Technical Services at: 1-800-343-2324 or 716-835-7000

2. System does not function even though suction is ON.

1. Filter life is expired. 2. An invalid filter has been inserted into the basket. 3. A filter has not been inserted into the filter basket.

1. Replace filter. 2/3. Insert a ViroSafe® RFID Filter

3. System is ON but suction is not working or is extremely minimal.

1. Filter is not completely seated in the basket. 2. Filter is clogged. 3. Vacuum hose is clogged or “kinked.” 4. Motor/ blower is obstructed.

1. Re-install ViroSafe Filter. Press firmly in place within the filter basket. 2. Replace filter. Ensure that ViroSafe EY filter and pre-filters are used for Erbium:YAG laser procedures. 3. Check or replace smoke evacuation tubing. 4. Call Buffalo Filter’s Technical Services at: 1-800-343-2324 or 716-835-7000

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7.0 Specifications The following table outlines the specifications for the PlumeSafe TURBO Auto-Sense.

Maximum Flow Setting

Tubing Diameter 1 3/8” (35 mm) 1 1/4” (32 mm) 7/8” (22 mm) 1/4” (6 mm)

Variable Flow Control

YES

Continuous Operation Motor

1 HP (0.75 kw)

Static Suction

85 inches H2O (211 mbar)

Noise Level (dBA)

58.3 maximum

Footswitch

YES- pneumatic

Certifications

UL, cUL, CE

Display

LCD

Voltages

100v- 132v, 220v- 240v, 50/60 Hz

Dimensions

13.75” x 8” x 17.23” (34.93cm x 20.32cm x 43.76cm)

Weight

13.75 lbs (6.24 kg)

Actual Flow Rates 79.0 CFM (2237 LPM) 67.9 CFM (1923 LPM) 44.4 CFM (1257 LPM) 05.2 CFM (0147 LPM)

8.0 Ordering Information To re-order disposables (filters, tubes, hoses), obtain replacement parts, or to return a unit for service, call Customer Service at: 800-343-2324 -or- (716) 835-7000, or contact your authorized BUFFALO FILTER Distributor/Representative.

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9.0 Equipment Return For the most efficient service, please follow the following procedures: Step 1: Record the serial number of the PlumeSafe TURBO-AS Smoke Evacuation 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 “Return Goods Authorization” (R.G.A.) number from Customer Service before returning the system. Step 4: If you have the original packing for your PlumeSafe Smoke Evacuation System, use it to properly return your unit. If you do not have the original packing material, ask Customer Service for advice on how to pack the unit for return shipment. Step 5: Freight for all returned goods should be prepaid by the shipper. Return to: BUFFALO FILTER 595 Commerce Drive Buffalo, New York 14228 Return merchandise must have a pre-authorized return number from Buffalo Filter and be marked with this number prior to returning. Transportation costs must be prepaid by the shipper and all risks of loss and damage of goods are the responsibility of the shipper. Unauthorized returns will be refused. Include a copy of the packing papers and/or invoice with the return. Exchange will be of an equivalent dollar value of returned merchandise less a restocking and handling fee on new, unused, unopened equipment or disposables. EXCEPTIONS 1. Defective merchandise may be returned for replacement only. Please contact Buffalo Filter Customer Service before shipping back merchandise. 2. Incorrectly shipped merchandise is exempt from restocking fees. Please contact Buffalo Filter customer service before shipping back merchandise.

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10.0 Terms CONFIDENTIAL INFORMATION The information, drawings, plans, and specifications being furnished by Buffalo Filter have been developed at Buffalo Filter's expense and shall not be used or disclosed by purchaser for any purpose other than to install, operate, and maintain the system supplied. CONSEQUENTIAL DAMAGES/LIMITS OF LIABILITY Buffalo Filter shall not in any case whatsoever be liable for special, incidental, indirect or consequential damages of any kind. In no case shall Buffalo Filter's liability exceed the amount paid Buffalo Filter by purchaser for the specific system giving rise to the liability. Purchaser agrees to indemnify and hold Buffalo Filter harmless from and against all liabilities, claims, and demands of third parties of any kind relating to the system and its use. ENTIRE AGREEMENT Purchaser by acceptance of Buffalo Filter's offer does acknowledge and agree to the terms and conditions contained herein. All matters involving the validity, interpretation and application of this agreement shall be controlled by the laws of New York State. Using any filter not manufactured by Buffalo Filter may cause damage to the system and will be cause for voiding the warranty. JURISDICTION Purchaser hereby consents to the jurisdiction of the New York Courts with respect to any controversy or dispute arising out of this agreement or the merchandise sold hereunder. SHIPMENT OF ORDER Buffalo Filter will attempt 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. Buffalo Filter's responsibility ceases with the safe delivery to the carrier at our dock. If the merchandise is damaged in transit, a claim must be made to the carrier involved. Buffalo Filter will assist customers in pursuing these claims.

11.0 Warranty Buffalo Filter warrants that the PlumeSafe TURBO Auto-Sense, manufactured by Buffalo Filter, shall be free from defects in material and workmanship. Products are warranted only to the extent that Buffalo Filter will replace without charge any filter systems proved to have defects within three (3) years of the date of delivery for P/N PSWTURBO AS and provided Buffalo Filter has been given the opportunity to inspect the system alleged to be defective and the installation or use thereof. No warranty is included for incidental or consequential damages of any nature arising from any defect. The warranty above is the only warranty made by Buffalo Filter and is expressly in lieu of all other warranties, expressed or implied, including, without limitation, the warranties of merchantability and fitness for a particular purpose. All warranties implied by any course of dealing or usage between parties are expressly excluded.

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© 2005 BUFFALO FILTER® 595 Commerce Drive Buffalo, New York USA 14228 Division of Medtek Devices, Inc. www.buffalofilter.com Customer Service 800-343-2324 (U.S. Only) (716) 835-7000