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MN009-940-S0 EN 

BOWA SHE SHA smoke evacuation unit  

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.  

 

 

Содержание SHE SHA

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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