Hazardous electro-surgical fumes Technical specifications

SHE SHA set

BOWA-electronic GmbH & Co. KGHeinrich-Hertz-Straße 4 – 1072810 Gomaringen I Germany

Telephone +49 (0) 7072-6002-0Telefax +49 (0) 7072-6002-33info@bowa.de I bowa.de

BO

WA-B

RO

-11672-S

HES

HA-E

N-2

017-0

5 P

rinte

d in

Ger

man

y W

e re

serv

e th

e rig

ht t

o m

ake

tech

nica

l and

str

uctu

ral a

men

dmen

ts C

opyr

ight

of B

OW

A-e

lect

roni

c, G

omar

inge

n

SHE SHA SMOKE EVACUATION SYSTEM SIMPLE TO HANDLE, CLEAN RESULTS

SHE SHA filterGerms and particulates

are filtered out

Face masksGerms and particulates

penetrate face masks

Warning of bio-hazard

Warning of a health risk

Possible health risks from surgical smoke plumes - Irritation of the eyes - Lacrimation - Sneezing - Nasopharyngeal irritation - Acute or chronic inflammatory

changes to the respiratory tract (bronchitis, asthma, emphysema)

- Headache - Weakness - Nausea, vomiting

- Anxiety / agitation - Hypoxia, dizziness - Colic - Cardiovascular problems - Hepatitis - HIV infection - Dermatitis - Anaemia - Leukaemia - Carcinoma

§ Overview of policies of individual countries LiteratureTechnische Regel für Gefahrstoffe (Technical Rule for Hazardous Substances) 525, TRGS 525 (2014).

ACoOR Nurses. Surgical Plume. Australian College of Operating Room Nurses 2006.

Arbejdstilsynet. At-intern instruks IN-17-3. Flere arbejdsmiljøemner: Arbejdstilsynet; 2007.

CS Association. Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings. Canadian Standards Association; 2013.

OSH Administration. OSH Act of 1970. Occupational Safety & Health Administration; 2004.

MaHPR Agency. Device Bulletin. Guidance on the safe use of lasers, intense light source systems and LEDs in medical, surgical, dental and aesthetic practices 2008.

Surgical Smoke: What we know, Association for Perioperative Practice (2009)

Acoustic emission Max. 55 dBA

Size (H x W x D) 6 inch x 11 inch x 15.5 inch (15 cm x 28 cm x 39.5 cm)

Flow rate Max. 708 liters per minute (with a 22-mm tube)

Weight 4.4 kg (5.5 kg including filter)

Filter type 4 layer filter (prefilter, ULPA, activated carbon, postfilter)

Particle size 0.1–0.2 µm at 99.999 % efficiency

Voltage 110–120 V / 220–240 V

TRGS 525TRGS 525, 8.1.2 Protective measures 09 / 2014

Australian College of Operating Room Nurses (ACORN)

Standard S20

Danish labor inspectorateAt-Instruction 4 / 2007 and 11 / 2008

Canadian Standards Association (CSA)

CSA Z301-13 Plume scavenging in surgical, diagnostic, therapeutic and aesthetic settings

Occupational Safety & Health Administration (OSHA)

General duty clause / Personal Protective Equipment (PPE)

Medicines and Health care products Regulatory Agency (MHRA)

MHRA DB2008(03) 04 / 2008

Association for Perioperative Practice (AfPP)

Standard 2.6 Lasers – standards and recommendations for safe perioperative practice

SHE SHASmoke evacuation system 950-001

SHE SHARemote sensor

included

Pneumaticfoot switch

included

Quiet and powerful Integrated aspiration System overview

The SHE SHA is simple to operate and various hoses and accessories are available for different applications. The quiet noise level and long service life of the 4-level filter with up to 35 hours of activation time have set a new standard.

The filter is automatically recognized and the remaining life is displayed. There are three different suction levels. Activation occurs fully automatically through a universal sensor that can be connected to any electro-surgical device and is only activated when fumes are present.

SHE SHA for effective electro-surgical smoke evacuation system

Filter status indicatorExtra-long filter life formax. 35 hours of activation

Quiet and powerfulMax. 55 db

(voice volume)

Simple to handleAutomatic plug’n play

filter recognitionCompact designSpace-saving as it is

stackable

Automatic activation Combinable

with all devices

3 power levelsAt the touch of a button

Foot switch and main switch For manual activation

The products have the CE marking according to directive 93 / 42 / EEC and comply with IEC 60601-2-2.

950-001 SHE SHA smoke evacuation system incl. remote sensor and pneumatic foot switch

951-001 SHE SHA filter for 35 hours (2 pcs.)

802-032 SHE SHA handle, 2 buttons, knife electrode, 3 m, single-use, sterile (10 pcs.) incl. holster

952-200 SHE SHA hose for laparoscopy, 3 m, single-use, sterile (12 pcs.)

952-001 SHE SHA hose for handle, 3 m, single-use, sterile (10 pcs.)

Connection to SHE SHA filterSimple to operate for effective working

Clip-onFor slim handles

Hose, handleand electrode Ready for immediate use with internal cable and anti-twist device

3 m

1 / 4" connection8.4 mm

3 / 8" connection9.5 mm

7 / 8" connection22 mm

3-port filterWith protection against accidental contact

1 / 4"[8,4 mm]

3 / 8"[9,5 mm]

7 / 8"[22 mm]

SHE SHA smoke evacuation system:

99.999 % filter efficiency

STERILE

STERILE

STERILE