PlumeSafe Turbo Operators Manual Sept 2021

For a period of three (3) years following the date of delivery, CONMED warrants the Turbo Auto-Sense™ against any defects in material or workmanship. CONMED will repair or replace (at CONMED’S option) the same without charge, provided that routine maintenance as specified in this manual has been performed using replacement parts approved by CONMED. This warranty is void if the product is used in a manner or for purposes other than intended.

BUFFALO FILTER

CONMED Corporation 525 French Road, Utica, NY 13502-5994 Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1 (727) 397-4540 email: [email protected] www.conmed.com

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 P000026047 C 09/2021 PlumeSafe® TURBO Auto-Sense™

MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, ANSI/AAMI ES60601-1 (2005, 3rd ed.), CAN/CSA C22.2 NO. 601.1, AND CAN/CSA-C22.2 No. 60601-1 (2008) 9D93 ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2019/(R)2012, and CSA CAN/CSA-C22.2 NO. 60601-1:14 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.

Table of Contents & List of Illustrations Section

Title

Page

1.0 1.1 1.2 1.3 1.4

SYSTEM DESCRIPTION Introduction Inspection Operational Information Cautions and Warnings

4

2.0 2.1 2.2 2.3 2.4

OPERATING INSTRUCTIONS System Controls ViroSafe® Filter Instructions Set-Up and Operation Performance References

13

3.0 3.1 3.2 3.3 3.4

MAINTENANCE General Maintenance Information Cleaning Periodic Inspection Troubleshooting the System

23

4.0 4.1 4.2

CUSTOMER SERVICE Equipment Return Ordering Information

24

5.0

TERMS & WARRANTY

25

Figure

Title

1

Control Panel

Page 13

System Description Section 1.0 1.1

Introduction

BUFFALO FILTER® Turbo Auto-Sense™ Smoke Evacuation Systems are intended to evacuate and filter surgical smoke plume and aerosols created by the interface surgical tools with tissue, examples being lasers, electrosurgery systems, and ultrasonic devices. The Turbo Auto-Sense™ Smoke Evacuation Systems have 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 ViroSafe® filter where the surgical smoke is processed by a series of filters. A single 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. One Buffalo Filter ViroSafe® filter contains four different stages within to capture the smoke plume. The first stage filtration is a prefilter whose function is to trap and remove gross particulate and casual fluid. The second stage filtration is ULPA grade (Ultra Low Penetration Air) filter whose high-tech patented (U.S. Patent #5874052) design captures particulates and micro-organisms from .1 to .2 microns at an efficiency of 99.999%. The third stage filtration uses the highest grade virgin activated carbon, especially designed for CONMED for the removal and adsorption of odors and toxic gases produced by burning tissues. These harmful gases may constitute a health hazard to healthcare professionals who are subjected to prolonged exposure. The activated carbon used in the Turbo Auto-Sense™ Smoke Evacuation Systems preferentially removes toxic organic gases rather than water vapor and provides optimal odor removal. The fourth stage filtration is an expanded foam used to trap activated carbon fines from migrating out of the filter. The electronic controls on the face panel of the Turbo Auto-Sense™ Smoke Evacuation System has been designed “user friendly” and facilitate unit set up and operation. Please refer to Section 2.0 for Operating Instructions.

1.2

Inspection

The Turbo Auto-Sense™ Smoke Evacuator has been thoroughly tested and inspected before shipment from the factory. Please check the unit before using it to insure that no damage has occurred in transit. If damage is evident, please contact CONMED Customer Service at 1-866-426-6633.

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In addition, please compare the accessories you receive with the standard accessories list below. If an item is missing, please notify CONMED Customer Service. Standard Accessories: • Operator’s Manual • Power Cord • Pneumatic Footswitch Please contact CONMED Customer Service to purchase the following accessories: • Replacement Filters • EZ Link® Remote Activator • 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. The information pertains to the use of the products both domestically and internationally: 1. T  he BUFFALO FILTER Turbo Auto-Sense™ Smoke Evacuation System(s) complies with IEC 60601.1 electrical specifications in the following systems: 100/120 VAC 50/60 Hz, 220/240 VAC 50/60 Hz 2. Type of protection against electrical shock (UL 60601-1, Clause 5.1): Class I 3. Degree of protection against electric shock (UL 60601-1, Clause 5.2); Type CF Applied Part 4. Degree of protection against ingress of water (UL 60601-1, Clause 5.3): IPX1 5. Method of sterilization or disinfection recommended by CONMED (UL 60601-1, Clause 5.4): Unplug Unit. Wipe unit with a damp cloth containing mild disinfectant solution or soapy water. Wipe dry with a clean cloth. Do not steam sterilize. 6. D  egree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide (UL 60601-1, Clause 5.5): Not Suitable 7. Mode of operation (UL 60601-1, Clause 5.6): Continuous 8. Upon request, CONMED will provide the following: Service and Repair Instructions, including Circuit Diagrams and Parts List 9. T  he fuses in the power entry module are to be serviced by an authorized CONMED technician as follows: 100/120 VAC, 50/60 Hz use 10 Amp 250 Volt Fuse (Slo-Blo) 220/240 VAC, 50/60 Hz use 8 Amp 250 Volt Fuse (Slo-Blo)

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10. This equipment needs special precautions regarding Electromagnetic Compatibility and needs to be installed according to EMC information found in this manual. 11. This equipment utilizes mobile RF communications equipment that can affect medical electrical equipment. 12. 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. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their expense. 13. This equipment operates in the following radio frequency specifications: RX modulation: Pulse-width coded, AM 100% modulation TX Frequencies: Manchester encoded, A = fc ± 423.75kHz, B = fc ± 484.29kHz Low bit: transition A to B High bit: transition B to A 14. To isolate equipment from supply mains, unplug the power cord from the appliance inlet on the unit or receptacle in the wall. Position the equipment to allow for ease of unplugging power cord. 15. Potential Equalization Conductor: Terminal located on back panel for connection of potential equalization. Conductor complies with requirements per IEC 60601-1 (2005). The Turbo Auto-Sense™ Smoke Evacuation System(s) and all filters are not intended for contact with patients.

1.4

Cautions and Warnings Please note that all Cautions and Warnings should be read and understood before any use of this equipment.

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1.4.1 WARNINGS: • Read this manual thoroughly, and be familiar with its contents prior to using this equipment. • Test this equipment prior to a surgical procedure. This product was thoroughly tested at the factory before shipment. • Disconnect the unit from the electrical outlet prior to inspecting system components. • The Turbo Auto-Sense™ system is only intended and suitable for the applications that are mentioned in the operating instructions. • The smoke evacuator produces a strong vacuum. Adjust the airflow and the position of the inlet end of the wand or tubing to prevent patient injury and to prevent suction of surgical materials and surgical specimens. • If the smoke evacuator is activated while the airflow is set to a high speed, it may produce a sudden, strong suction action. Check the airflow setting before activating the smoke evacuator to prevent patient injury and to prevent suction of surgical materials and surgical specimens. • To maximize patient safety, the tubing or wand should not come into direct contact with tissue. Otherwise, patient injury may result. • The BUFFALO FILTER ViroSafe® filters and single-use accessories are completely disposable. Please dispose of according to your local codes or regulations and hospital policy. These filters may be disposed of or incinerated, whichever is appropriate for your institution. • Care should be taken to route the power cord, foot pedal, smoke evacuation tubing, and EZ Link cable as to not cause a tripping hazard or crimping of cords. • Do not operate this device in the presence of flammable or explosive gases. • This equipment is intended for use by 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 Turbo Auto-Sense™ or shielding the location. • The use of ACCESSORIES other than those specified by CONMED, or sold by CONMED as replacement parts for internal components, may result in increased emissions or decreased immunity of the Turbo Auto-Sense™. • This equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use in necessary, the Turbo Auto-Sense™ should be observed to verify normal operation in the configuration in which it will be used.

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• Refer routine servicing to qualified biomedical technical personnel. • Changes or modifications not expressly approved by CONMED could void the manufacturer’s warranty. • To avoid risk of Electric Shock, this equipment must only be connected to a supply mains with protective earth. 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. • 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 fail. • Using any other filter or accessory not supplied by CONMED may cause damage and/or cause the system to be inoperable and may void the warranty. • Care must be exercised in the installation of hoses, adapters and suction canisters. Failure to follow the procedures outlined in this manual may result in overheating of the motor and may void the unit warranty. • When using an accessory that will be connected to a surgical cannula, ensure that a mechanical means of closing the flow to the evacuator is available, such as a stopcock to prevent unwanted loss of pneumo gasses during the procedure or in case of system failure. • 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. • The ViroSafe® Filter should be changed according to the life of the filter. The ViroSafe® Filter, used with the Turbo Auto-Sense™ Smoke Evacuation System(s), should not be used for more the time specified for each filter. Failure to change the filter may result in decreased efficiency and contamination of the electric motor, vacuum pump, and sound absorbing media within the unit. • Do not block either the tubing or the filter during operation. An occlusion or significant restriction may cause the motor to overheat and the unit to stop working.

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• The installation of this equipment must be performed such that the intake and exhaust vents located on the bottom of the system are not obstructed. Failure to properly install the unit may cause reduced performance, damage and/or cause the system to be inoperable and may void the warranty. • The ambient temperature during operation must be kept between 50°F to 104°F (10°C to 40°C). • The relative humidity during operation must be kept between 10% to 75%. • An atmospheric pressure range of 700 hPA to 1,060 hPa. • Storage environmental ambient temperature 14°F to140°F (-10°C to 60°C). • Storage environmental relative humidity 10% to 75%. There are no user serviceable components in the Turbo Auto-Sense™ Smoke Evacuation System(s). Refer service to qualified service personnel. Use only with the power cord provided and always plug into a grounded outlet. European Commission requires that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Turbo Auto-Sense™ Operator’s Manual    Page 9

Symbol

Description / Meaning DANGER HIGH VOLTAGE CAUTION ELECTRICAL SHOCK HAZARD. DO NOT REMOVE COVER. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. WARNING

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

Turbo Auto-Sense™ Operator’s Manual    Page 10

Symbol

Description / Meaning CATALOG NUMBER

PRESCRIPTION ONLY

CE MARK

NOT MADE WITH NATURAL RUBBER LATEX

MEDICAL DEVICE

EC REP

SERIAL NUMBER

Turbo Auto-Sense™ Operator’s Manual    Page 11

Symbol

Description / Meaning

CONSULT INSTRUCTIONS/DIRECTIONS FOR USE

TO INDICATE THE PRESENCE OF THE RFID TAG INCORPORATED WITHIN THE PACKAGING, CONTAINER, OR EQUIPMENT WITHOUT IDENTIFYING THE SPECIFIC AIR INTERFACE OR DATA STRUCTURE EMPLOYED.

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Operating Instructions Section 2.0 2.1

System Controls

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

Suction Motor ON/OFF TURBO Mode Button Decrease Suction

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. B U F FA L O F I LT E R When the unit is powered on the INSERT VIROSAFE following LCD screen will appear. F I LT E R After inserting a filter a screen will B U F FA L O F I LT E R flash for a few seconds to indicate filter type and original life. VIROSAFE-XLL 1 8 HOUR FILTER Next, the standard screen will appear Virosafe-XLL HR-MN which displays information regarding Time Remaining 17-31 the unit’s current activity. Suction Setting 0% Mode-NORML Motor-OFF

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). It is recommended that you select the lowest suction setting that effectively clears the operative field of surgical smoke.

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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 R E P L A C E F I LT E R 0 0 - 0 0 Suction Setting 100% Mode-NORML Motor-ON

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. EZ LINK® REMOTE ACTIVATION DEVICE (EZLINK01) For directions on using the EZ Link®, see instructions accompanying the EZLINK01. 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.

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SERVICE When a service message appears, please contact CONMED 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 CONMED.

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

Brush Hours = 500 IF OVER 500HRS CALL: 1-800-343-2324 1-716-835-7000 F I LT E R I . D . E R R O R ! CALL FOR SERVICE 1-800-343-2324 1-716-835-7000

SETTING THE DEFAULT LANGUAGE 1. Turn the main 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 simultanously. 5. Repeat step 2.

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2.2

ViroSafe® Filter Instructions

CONMED Part Number: Configuration: ViroSafe® Filters - Multi Port Filter: Filter(s): Particle Size, µm: Filter Life: Filter Life Indicator: ViroSafe® Filter P/N:

PSWTURBO AS & PSWTURBO AS/220 Portable or tabletop 4-Stage Filtration In One Casing, (Pre-Filter, ULPA, Carbon, Post-Filter) ULPA 0.1 to 0.2 Microns At 99.999% Efficiency Automatic Factory Set Filter Sensor Timed Replacement (Call for selection)

NOTE: Before installing or removing any filter, be sure that the system is turned off. Filter Installation Instructions: The installation of the ViroSafe® Filter into the BUFFALO FILTER Turbo Auto-Sense™ Smoke Evacuation System(s) is quick and simple. 1. Remove the ViroSafe® Filter from the shipping box and discard any protective wrapping. Examine all filters for damage during shipping and storage. Do not install any filter with visible signs of structural damage. 2. Insert the ViroSafe® Filter into the filter receptacle. Be sure that the filter is seated completely against the bottom of the filter chamber. WARNING: This device is not intended for evacuation of fluid. If fluid is expected to be aspirated using the ViroSafe® Filter or the BUFFALO FILTER Turbo Auto-Sense™ 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. Filter Removal Instructions: 1. After the ViroSafe® Filter has been exhausted and requires changing, turn the smoke evacuation system off and disconnect any accessory tubing attached to the filter. 2. Pull the ViroSafe® Filter from the smoke evacuation system and dispose of in accordance with hospital policy. The ViroSafe® Filter may be disposed of or incinerated. 3. Clean the unit with appropriate germicide prior to re-use. Follow the indicated instructions for maintenance and installation of a new ViroSafe® Filter. CAUTION: Using any other filter or accessory not supplied by CONMED may cause damage to the system and/or cause the system to be inoperable and may void the warranty. WARNING: The ViroSafe® Filter should be changed when the Filter Life Indicator on the LCD displays “REPLACE”. Failure to change this filter may result in decreased efficiency and contamination of the electric motor, vacuum pump, and sound absorbing media within the system, or non-operation of smoke evacuator. Turbo Auto-Sense™ Operator’s Manual    Page 16

2.3

Set-Up and Operation

The operation of the Turbo Auto-Sense™ Smoke Evacuation System is as follows: 1. Install the ViroSafe® Filter. 2. Attach unit power cord to the receptacle on the rear of the system. Plug the pronged power cord into an appropriate grounded power outlet. Route power cord in such a way as to minimize potential trip hazard by users or patients or pinch hazard that could cause electric shock. 3. Optional: Attach either EZ Link® or Footswitch plug into approprate jack on rear or side of machine. Route footswitch or cord in such a way as to minimize potential trip hazard by users or patients or pinch hazard that could result in unreliable operation. 4. Ensure that the evacuation tubing is fully seated in the inlet of the filter. Route tubing in such a way as to minimize potential trip hazard by users or patients. 5. Activate the power unit by: a. Toggle the rocker switch on the rear of the unit to the ON position, or b. Depressing and releasing the footswitch (if connected), or c. Activating either CUT or COAG on the Electrosurgical Pencil (if EZ Link is connected). 6. Adjust the suction level to the desired setting by pressing the UP/DOWN arrow button while the unit is activated. Noise created by the smoke excavation power unit may be minimized by selecting the lowest vacuum setting that effectively clears the operative field of surgical smoke. 7. Deactivate the unit by: a. Toggle the rocker switch on the rear of the unit to the OFF position, or b. Depressing and releasing the footswitch (if connected), or c. Releasing either the CUT or COAG button on the Electrosurgical Pencil (If EZ Link is connected). 8. Replace the ViroSafe® Filter when the Filter Life Remaining indicator on the LCD Display flashes REPLACE FILTER. Failure to change the filter will affect the performance of the system.

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2.4

Performance References* PERFORMANCE* Model Number Maximum Flow Setting (CFM-U.S.)

Turbo Auto-Sense™ 110v

Standard Hose I. D. 1 3/8” 1 1/4” 7/8” 1/4”

79 CFM 67.9 CFM 44 CFM 5.2 CFM

Standard Hose I. D. 35mm 2237 LPM 32mm 1923 LPM 22mm 1257 LPM 6.4mm 147 LPM Dimensions (H x W x D)

inches

13.75 x 8 x 17.23

Dimensions (H x W x D)

centimeters

34.93 x 20.32 x 43.76

Weight

lbs (kg.)

13.75 (6.24)

Noise Level, dBA

MAXIMUM** 58 dB

Footswitch Pneumatic

Standard

Remote Control Activation

YES (optional)

Safety Features

UL Classified CE Marked Fuse Protection

Display

LCD Filter Status Flow Rate Service Required

Voltage Available

100/120 VAC

Frequency, auto sensed

50/60 Hz

Variable Flow Control Motor Motor Static Suction

Yes Watts

1000 ±10% 85 inches H2O

(6.5 mm orifice) (211 mbar)

*For reference purposes only **using a new 7/8” x 6’ hose

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PERFORMANCE* Model Number

Turbo Auto-Sense™ 220v

Maximum Flow Setting (CFM-U.S.) Standard Hose I. D. 1 1/4” 43 CFM 7/8” 35 CFM 1/4” 2 CFM Standard Hose I. D. 35mm 1218 LPM

Dimensions (H x W x D)

22mm 991 LPM 6.4mm 56 LPM inches 6 x 11 x 15.5

Dimensions (H x W x D)

centimeters

15.2 x 27.9 x 39.4

Weight

lbs (kg.)

4.3

Noise Level, dBA

MAXIMUM** 60 dB

Footswitch Pneumatic Remote Control Activation Safety Features

Standard YES (optional) UL Classified CE Marked Fuse Protection

Display

LCD Filter Status Flow Rate Service Required

Voltage Available

220/240 VAC

Frequency, auto sensed

50/60 Hz

Variable Flow Control

Yes

Motor Motor Static Suction

Watts kPa

1000 ±10%

(6.5 mm orifice) (21.1)

*For reference purposes only **using a new 7/8” x 6’ hose

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Table 1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Smoke Evacuation System Model Turbo Auto-Sense™ is intended for use in the electromagnetic environment specified below. The customer or user of the Turbo Auto-Sense™ should assure that it is used in such an environment. Emissions Test RF Emissions

Compliance

Electromagnetic Environment - Guidance

Group 1

The Turbo Auto-Sense™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

The Model Turbo Auto-Sense™ is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Class A

Not applicable.

Class A

Not applicable.

CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

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