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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 % U

T

 

(>95 % dip in U

T

for 0.5 cycle 
 
40 % U

T

 

(60 % dip in U

T

for 5 cycles 
 
70 %  U

T

 

(30 % dip in U

T

for 25 cycles 
 
<5 % U

T

 

(>95 % dip in U

T

for 5 sec 

<5 % U

T

 

(>95 % dip in 
U

T

for 0.5 cycle 
 
40 % U

T

 

(60 % dip in U

T

for 5 cycles 
 
70 % U

T

 

(30 % dip in U

T

for 25 cycles 
 
<5 % U

T

 

(>95 % dip in 
U

T

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.  

Summary of Contents for SHE SHA

Page 1: ...SHE SHA SMOKE EVACUATION UNIT OPERATING MANUAL...

Page 2: ...OCK 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 th...

Page 3: ...utions 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 Electroma...

Page 4: ...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...

Page 5: ...th 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 a...

Page 6: ...uction 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 t...

Page 7: ...ion 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 s...

Page 8: ...ssembly 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...

Page 9: ...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...

Page 10: ...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...

Page 11: ...E 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...

Page 12: ...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...

Page 13: ...dby 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 Confi...

Page 14: ...y 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 accesso...

Page 15: ...n 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 swit...

Page 16: ...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...

Page 17: ...ctromagnetic 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 interf...

Page 18: ...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 environ...

Page 19: ...bles 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...

Page 20: ...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...

Page 21: ...by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the model SHE SHA as recommended below according to the maximum output power of the communica...

Page 22: ...ast every year This inspection should include checks for Damage to the power cord Damage to the power plug or power inlet module Proper mating cleanliness and absence of damage to the filter inlet Obv...

Page 23: ...4 Call BOWA Technical Services 2 Smoke Evacuation System does not function even though suction ON button is depressed 1 Not plugged into an electrical outlet 2 Fuses are blown 3 Electronic system fail...

Page 24: ...r com NL 2513 BH The Hague The Netherlands Distributed by BOWA electronic GmbH Co KG Heinrich Hertz Stra e 4 10 72810 Gomaringen Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 info bowa medical...

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