SHE SHA Operating Manual March 2021

The revision level of this manual is specified in the footer of the user manual.

Unit Serial Number ______________________

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE ANSI/AAMI ES60601-1:A1:2012, 1:2009/(R)2012 and A2:2010/(R)2012, and CSA CAN/CSA-C22.2 NO. 60601-1:14 E349034 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.

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Table of Contents 1

2

3

4.

System Description ... 4 1.1

Introduction ... 4

1.2

Inspection ... 5

1.3

Operational Information ... 5

1.4

Cautions and Warnings ... 7

1.4.1

Warnings ... 7

1.4.2

Cautions ... 8

Operating Instructions ... 10 2.1

User Interface Components ... 10

2.2

SHE SHA Filter Instructions ... 13

2.3

Set-Up and Operation ... 15

2.4

Technical data SHE SHA Smoke Evacuation System ... 16

2.5

Electromagnetic Compatibility Information per IEC60601-1-2 ... 17

Maintenance ... 21 3.1

General Maintenance Information ... 21

3.2

Cleaning ... 21

3.3

Periodic Inspection ... 21

3.4

Repairs ... 22

3.5

Troubleshooting the System – see below... 22 Technical Service... 23

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1 System Description

1.1

Introduction BOWA SHE SHA smoke evacuation units 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 SHE SHA Smoke Evacuation Units have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the SHE SHA 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 BOWA SHE SHA 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 for the removal and adsorption of odors and toxic gases produced by strong heating of biological tissue. These harmful gases may constitute a health hazard to healthcare professionals who are subjected to prolonged exposure. The activated carbon used in the SHE SHA 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 front panel of the SHE SHA Smoke Evacuation System have been designed user friendly and facilitate unit set up and operation. Please refer to Section 2.0 for Operating Instructions.

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1.2

Inspection The SHE SHA 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 the Technical Service, see chapter 4 technical service. In addition, please compare the accessories you receive with the standard accessories list below. If an item is missing, please notify BOWA Customer Service. Standard Accessories: • Operating Manual • Power Cord • Pneumatic Foot switch • Remote Switch Activator Please contact BOWA Customer Service to purchase the following accessories: • Replacement Filters • Hoses, Tubing, Adapters, Handles & 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.

The BOWA SHE SHA Smoke Evacuation System(s) complies with IEC 60601-1 electrical specifications in the following systems: 220/240 VAC 50/60 Hz 100/120 VAC 50/60 Hz

2.

Type of protection against electrical shock: Class I

3.

Degree of protection against electric shock: Type CF Applied Part

4.

Degree of protection against ingress of water: IPX1

5.

Method of sterilization or disinfection recommended by BOWA: 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.

Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide: Not Suitable

7.

Mode of operation: Continuous

8.

The fuses on the circuit board are to be serviced by an authorized BOWA technician as follows: 220/240 VAC, 50/60 Hz use 8 Amp 250 Volt Fuse (Slo-Blo), (F1,F2) 100/120 VAC, 50/60 Hz use 10 Amp 250 Volt Fuse (Slo-Blo), (F1,F2)

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9.

This equipment needs special precautions regarding Electro Magnetic Compatibility and needs to be installed according to EMC information found in this manual.

10. This equipment utilizes mobile RF communications equipment that can affect medical electrical equipment. 11. 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. 12. This equipment operates in the following radio frequency specifications: RX modulation: Pulse-width coded, AM 100% modulation TX Frequencies: Manchester encoded, A = fc = / -423.75 kHz, B = fc +/- 484.29 kHz Low bit: transition A to B High bit: transition B to A 13. To isolate equipment from supply mains, unplug the power cord from the appliance inlet on the unit or receptacle. Position the equipment to allow for ease of unplugging power cord. 14. Potential Equalization Conductor: Terminal located on back panel for connection of potential equalization. Conductor complies with requirements per IEC 60601-1. The SHE SHA Smoke Evacuation System(s) and all filters are not intended for contact with patients.

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1.4

Cautions and Warnings

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

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 SHE SHA 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 or turn on the occlusion detection to avoid undesired tissue suction, see chapter 2.1 occlusion detection.

•

To maximize patient safety, the tubing or wand should not come into direct contact with tissue. Otherwise, patient injury may result.

•

The BOWA SHE SHA 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, the foot pedal and smoke evacuation tubing and the remote switch activator 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 SHE SHA or shielding the location.

•

The use of ACCESSORIES other than those specified by BOWA, or sold by BOWA as replacement parts for internal components, may result in increased emissions or decreased immunity of the SHE SHA.

•

This equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use in necessary, the SHE SHA 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 BOWA 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.

1.4.2 Cautions •

This device must 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 BOWA may cause damage and/or cause the system to be inoperable.

•

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.

•

This device is not intended for evacuation of fluid. If fluid is expected to be aspirated to the SHE SHA 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 SHE SHA filter should be changed according to the life of the filter. The SHE SHA filter, used with the SHE SHA 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.

•

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 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 -10°C to 60°C.

•

Storage environmental relative humidity 10% to 75%.

There are no user serviceable components in the SHE SHA 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.

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Explanation of Symbols Symbol

Description / Meaning Danger high voltage Caution- Electrical shock hazard, do not remove cover, refer servicing to qualified service personnel 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

WEEE symbol: Requires separate collection for waste from electrical and electronic equipment.

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2 Operating Instructions

2.1

User Interface Components The electronic system controls on the SHE SHA Smoke Evacuation System are easy to understand and simple to use. The membrane control panel contains the suction on/off switch, suction power adjustment, filter life indicator, and service indicator light.

1

3 2

5

4

6 7

8

1. 2. 3. 4. 5. 6. 7. 8.

ON/OFF button Orange Standby LED Green fan ON LED Speed Select Button Suction Levels LED Filter Life Indicator LED Service LED Foot switch socket

NOTE Please be sure to read all instructions before installing accessories or operating this equipment. Failure to do so may result in damage to the unit and /or personal injury.

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• SUCTION ON & Standby  Connect power cord to a grounded outlet and the appliance inlet on the back of the unit  Orange standby LED illuminates on keypad  Power has been applied  Press ON/OFF button  Green fan ON LED illuminates on keypad  Suction is activated  Press ON/OFF button again  Orange standby LED illuminates on keypad  Suction is disabled  Unplug power cord from the unit or receptacle  Main power is turned off

• SUCTION CONTROL (Membrane Control Panel) The amount of suction may be adjusted by pressing the suction control button. Each time the suction control button is depressed, the motor speed in increased. Once the suction has reached the maximum level, depressing the button again will return suction level to lowest setting. The suction control should be set at the lowest practical setting to completely remove the surgical smoke from the operative site. Each time the speed select button is pressed, the suction will change to a different flow setting (low / medium / high).

• FOOT SWITCH / REMOTE SWITCH ACTIVATOR (Membrane Control Panel) The SHE SHA Smoke Evacuation System also comes equipped with a pneumatic foot switch and remote switch activator. Connect the cable of the foot switch to the corresponding socket on the front panel. When the foot switch is plugged in, the unit may be turned on or off by depressing the foot switch pedal once for each operation. For remote activation connect the remote switch activator to the corresponding socket on the rear side of the unit. Place a monopolar cable to the clip of the remote switch. As soon as electrosurgery is being activated the smoke evacuation will start suction automatically. There is a possibility to set a delay time to extend suction by depressing the clock symbol on the remote switch activator, please see instructions that accompany that product.

• FILTER LIFE INDICATOR

(Membrane Control Panel) The filter life indicator on the membrane control panel provides a visual indication of the status of the life of the filter in use. The filter life indicator for the SHE SHA Smoke Evacuation System will automatically adjust according to the flow setting selected. Low Flow Setting = 35 hours of filter life Medium Flow Setting = 24 hours of filter life High Flow Setting = 18 hours of filter life The SHE SHA Filter Life Indicator is factory set. All filter life timing is automatic.

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Reading the Filter Life Indicator: Install an unused SHE SHA filter into the system per the installation instructions contained in this operator’s manual. When the system is turned on, the filter life indicator will light up the top orange filter life indicator LED, indicating 100% filter life. The indicator will progress through vertically allocated LED and the lowest LED will begin flashing RED to indicate that the filter has expended its useful life and requires replacement. When the maximum filter life is consumed and the smoke evacuator is not powered off for greater than six (6) hours or the main power is disconnected – a new filter is required to activate the smoke evacuator and make operational.

• FUSES

(circuit board) Two 8 AMP fuses (220/240 VAC) or two 10 AMP fuses (100/120 VAC) are located on the circuit board within the housing of the system. It electrically protects both the system 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 BOWA’s technical service for system service instructions, see chapter 4 technical service. •

OCCLUSION DETECTION The SHE SHA unit provides an occlusion detection feature to avoid undesired tissue suction for maximum patient safety. The LED codes shown in the table below indicate if the occlusion detection is enabled or disabled and if an occlusion is detected. LED Functions On LED

Meaning and corrective measures Standby LED Unit in Standby, Occlusion Detection disabled

Unit in Standby, Occlusion Detection enabled

Unit running, Occlusion Detection disabled

Unit running, Occlusion Detection enabled Unit is stopped due to a detected Occlusion ➔ Must be restarted by pressing On / Standby button or remote switch activator

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Occlusion detected 1. Suction motor stops 2. The Green fan ON & Orange Standby LED's toggle back and forth 3. The suction has to be manually started by pressing the On / Standby button or remote switch activator

Occlusion detection enabling /disabling

2.2

 

Press and hold the speed select button for over 5 seconds. The Orange Standby LED starts blinking if the occlusion detection is enabled



The Orange Standby LED stops blinking if the occlusion detection is disabled

SHE SHA Filter Instructions

BOWA Filter REF 951-001 Configuration

Portable or tabletop

SHE SHA Filter - Multi Port Filter

4-Stage Filtration in One Casing, (Pre-Filter, ULPA, Carbon, Post-Filter)

Filter(s)

ULPA

Particle Size, µm

0.1 to 0.2 Microns at 99.999% Efficiency

Filter Life

Automatic Factory Set Filter Sensor

Filter Life Indicator

Time Replacement

NOTE Before installing or removing any filter, be sure that the system is turned off.

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Filter Installation Instructions: The installation of the filter into the BOWA SHE SHA Smoke Evacuation System is quick and simple. 1.

2.

Remove the 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. Insert the filter into the 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 filter or the BOWA SHE SHA 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. 2. 3.

After the filter has been exhausted and requires changing, turn the Smoke Evacuation System off and disconnect any accessory tubing attached to the filter. Depress the filter tab and pull the filter from the Smoke Evacuation System and dispose of in accordance with hospital policy. The filter may be disposed of or incinerated. Clean the unit with appropriate germicide prior to re-use. Follow the indicated instructions for maintenance and installation of a new filter.

CAUTION: Using any other filter or accessory not supplied by BOWA may cause damage to the system and/or cause the system to be inoperable and may void the warranty. WARNING: The filter should be changed when the Filter Life Indicator shows red flashing LED (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.

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2.3

Set-Up and Operation The operation of the SHE SHA Smoke Evacuation System is as follows: 1.

Install the 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.

Either plug the remote switch activator into the jack on the rear side of the unit and place the monopolar cables to the clip of the remote switch or attach the foot switch tubing into the appropriate socket on the front panel. Route the foot switch or remote switch tubing 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. Pressing the suction ON/OFF switch on the membrane panel, b. Depressing and releasing the foot switch (if connected), or c. Activating either CUT or COAG on the electrosurgical pencil (if the remote switch is connected).

6.

Adjust the suction level to the desired setting by pressing the speed select 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. Pressing the suction ON/OFF switch on the membrane panel, b. Depressing and releasing the foot switch (if connected), or c. Releasing either the CUT or COAG button on the electrosurgical pencil (if the remote switch is connected).

8.

Replace the filter when the Filter Life Indicator LED flashes red (0% Life Remaining). Failure to change the filter will affect the performance of the system.

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2.4

Technical data SHE SHA Smoke Evacuation System

Performance Model Number

950-001

Maximum Flow Setting (CFM-U.S.) Standard Hose I.D.

22 mm (7/8’’) - 708 LPM (25 CFM) 9.5 mm (3/8’’) - 130 LPM (4.5 CFM) 6.4 mm (1/4’’) - 57 LPM (2 CFM)

Dimensions (H x W x D )

152 mm x 279 mm x 394 mm (6’’ x 11’’ x 15.5‘’)

Weight

4.4 kg (5.5 kg incl. filter)

Noise Level, dBA

max. 55.0 dBA

Foot switch Pneumatic

Standard

Remote Control Activation

YES

Safety Features

UL Classified CE Marked Fuse protection

Display

LED Filter Status Flow Rate Service Required

Voltage Available

220/240 VAC, 100/120 VAC

Frequency, auto sensed

50/60 Hz

Variable Flow Control

Yes

Motor

1000 W ± 10%

Motor Static Suction

25.69 kPa (6.5 mm orifice)

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2.5

Electromagnetic Compatibility Information per IEC60601-1-2

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Surgical Smoke Plume Evacuator model SHE SHA is intended for use in the electromagnetic environment specified below. The customer or user of the SHE SHA should assure that it is used in such an environment. Emissions Test RF Emissions

Compliance

Electromagnetic Environment - Guidance

Group 1

The SHE SHA 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 SHE SHA 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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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Model SHE SHA is intended for use in the electromagnetic environment specified below. The customer or user of the Model SHE SHA should assure that it is used in such an environment. Immunity Test Electromagnetic discharge (ESD)

IEC 60601 Test Level

Compliance Level

+8 kV contact

+8 kV contact

+15 kV air

+15 kV air

Electrical fast transient/burst

+2 kV for power supply lines

+2 kV for power supply lines

IEC 61000-4-4

+1 kV for input/output lines

+1 kV for input/output lines

Surge

+1 kV differential mode

+1 kV differential mode

+2 kV common mode

+2 kV common mode

Voltage dips, short interruptions, and voltage variations on power supply input lines.

<0 % UT for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

<0 % UT for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

IEC 61000-4-11

0 % UT (60 % dip in UT) for 1 cycle

0 % UT (60 % dip in UT) for 5 cycles

70 % UT for 25/30 cycles

70 % UT for 25/30 cycles

Single phase: at 0°

Single phase: at 0°

0° at UT: 250/300 cycles

0° at UT: 250/300 cycles

30 A/m

30 A/m

IEC 61000-4-2

IEC 61000-4-5

Power frequency (50/60 Hz) magnetic field

Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30--%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Model SHE SHA requires continued operation during power mains interruptions, it is recommended that the Model SHE SHA be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8

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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The model SHE SHA is intended for use in the electromagnetic environment specified below. The customer or user of the model SHE SHA should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the BOWA SHE SHA smoke evacuation unit including cables, than 30cm (12 in).

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.7 GHz

3 V/m

80% AM at 1kHz

3 Vrms

Conducted RF

IEC 61000-4-6

3 Vrms 0.15MHz 80MHz 6 Vrms in ISM bands between 0.15MHz and 80 MHz 80% AM at 1 kHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

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NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structure, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model EVL is used exceeds the applicable RF compliance level above, the model SHE SHA should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model SHE SHA. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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