Bowa SHE SHA User manual

SHE SHA
SMOKE EVACUATION UNIT
OPERATING MANUAL

2 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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 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
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.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 3
Table of Contents
1. 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
2. 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
3. Maintenance…………………………………………………………………….. 22
3.1 General Maintenance Information……………………………………………. 22
3.2 Cleaning…………………………………………………………………………. 22
3.3 Periodic Inspection……………………………………………………………...22
3.4 Repairs…………………………………………………………………………...22
3.5 Troubleshooting………………………………………………………………… 23
4. Technical Service………………………………………………………………. 23

4 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 5
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 IEC60601.1 electrical
specifications in the following systems:
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 BOWA (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. Degree 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, BOWA will provide the following:
Service and Repair Instructions, including Circuit Diagrams and Parts List
9. 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)

6 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
10. This equipment needs special precautions regarding Electro Magnetic 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 = / -423.75 kHz, B = fc +/- 484.29 kHz
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. 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 SHE SHA Smoke Evacuation System(s) and all filters are not intended for contact with patients.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 7
Please note that all Cautions and Warnings should be read and
understood before any use of this equipment.
1.4 Cautions and Warnings
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, foot pedal, smoke evacuation tubing, and 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.

8 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
•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.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 9
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
IXP1
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

10 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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. ON/OFF button
2. Orange Standby LED
3. Green fan ON LED
4. Speed Select Button
5. Suction Levels LED
6. Filter Life Indicator LED
7. Service LED
8. 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.
1
3
2
4
5
8
6
7

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 11
•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.

12 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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 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
Meaning and corrective measures
On LED
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

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 13
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
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
2.2 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.

14 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
Filter Installation Instructions:
The installation of the filter into the BOWA SHE SHA Smoke Evacuation System is quick and
simple.
1. 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.
2. 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. After the filter has been exhausted and requires changing, turn the Smoke Evacuation System
off and disconnect any accessory tubing attached to the filter.
2. 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.
3. 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.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 15
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. Attach either remote switch activator in 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 cable into the
appropriate socket on the front panel. Route foot switch or remote switch 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. 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 minimizedby 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.

16 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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
Frequency, auto sensed
50/60 Hz
Variable Flow Control
Yes
Motor
1000 W ± 10%
Motor Static Suction
25.69 kPa (6.5 mm orifice)

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 17
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
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
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.
RF Emissions
CISPR 11
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.
Harmonic
Emissions
IEC 61000-3-2
Class A
Not applicable.
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Class A
Not applicable.

18 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30--%.
Electrical fast
transient/burst
IEC 61000-4-4
+2 kV for power
supply lines
+1 kV for
input/output lines
+2 kV for power
supply lines
+1 kV for
input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+1 kV differential
mode
+2 kV common
mode
+1 kV differential
mode
+2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines.
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in
UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 sec
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
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.

MN009-940-S0 EN BOWA SHE SHA smoke evacuation unit 19
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 Model
EVL including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Radiated RF
3 V/m
d = 1.7 √P 80 MHz to 800 MHz
IEC 61000-4-3
80 MHz to 2.5
GHz
3 V/m
d = 2.3 √P 800 MHz to 2.5 GHz
3 Vrms
d = [3.5/V1} √P
Conducted RF
IEC 61000-4-6
150 kHz to 80
MHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

20 BOWA SHE SHA smoke evacuation unit MN009-940-S0 EN
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.
aField 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.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.