Sio-med product catalogue

Page 1

OR-gowns OR-drapes

i Product catalogue i


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System Surgical Solutions

Always the right product The surgical solutions®-OR system has been

objective test methods, hence they are positioned

developed in cooperation between one of the leading

in the top with regards to comfort of a liquid proof

Textile Service companies in Germany and Sioen

OR gown. Gore™ Liquid Proof Fabric (CLIP) –

with its specialized branch SIOMED.

Heart of the system OR drapes made out Gore™

The surgical solutions -OR system doesn’t

CLIP can score with outstanding characteristics

make any compromises with regards to safety

as components in the critical area. CLIP offers a

and comfort for the patient and the OR team.

unique weight per square metre, which provides best

The surgical solutions -OR system uses

handling in the end use, optimum drape ability and

GORE™ Medical Fabrics which are especially

end user friendly modeling to the patient skin. Good

developed for the demanding end-use conditions

liquid absorption, in order to provide suitable liquid

in the High-Performance area. With regards to the

management, completes the picture.

liquid barrier requirements of the European norm

The 3-layer membrane of the laminate offers thermal

EN 13795 they outperform easily these requirements,

insulation for the patient and avoid that the patient

which are based on a barrier > 100 mbar against

body can cool down also in case of long and

water (H²O). All GORE™ Medical Fabrics provide an

extensive surgeries.

®

®

additional barrier of > 200 mbar against all liquids such as blood, iodine and disinfectants which are more likely to be encountered in the operating room. Furthermore, they provide an effective barrier against bacteria penetration and viruses. Insofar as wearer comfort is concerned, the textiles generate a main quality criteria within the surgical solutions®-OR system. The physiological function of OR gowns contains much more than the term „well-being“. Thanks the highly breathable ePTFE membrane the performance of the wearer under stressed climate and working environment will be improved, and the heat stress of the OR staff will be reduced. For liquid proof gowns with low breathability an impairment of the mental performance and concentration of the

4 drape system

OR staff is noted. OR gowns made out of GORE™

Critical area - Gore™ CLIP

Liquid Proof Fabric (CLIP) do have a water vapour

Less Critical area - SIOMED

transmission resistance (Ret) of <6 measured with

2

OR gown

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Construction

Technical specification - Gore™ Liquid Proof Fabric (CLIP) Colour:

Blue 3-layer laminate

Surgeon side (dark)

PES knit

Barrier layer

ePTFE-Membrane with production number printed on it to facilitate traceability

Patient side (light)

PES knit

Requirements Certification criteria in accordance with EN 13795

Unit of measurement

Standard Performance

High Performance

Value

Value EOL(2)

Critical area

Barrier

Resistance to bacteria penetration Dry

Log10 KBE

not relevant

not relevant

0

0

Wet

Bl

≥ 2,8

6,0

6,0

6,0

cm H2O

≥ 20

≥ 100

> 200

> 200

KBE/dm2

≤ 300

≤ 300

_3)

_3)

IPM

≤ 3,5

≤ 3,5

≤ 3,5 4)5)

≤ 3,5 4)5)

Log10 Partikel (3-25 μm)

≤ 4,0

≤ 4,0

≤ 4,0

≤ 4,0

Dry

kPa

≥ 40

≥ 40

> 250

> 150

Wet

kPa

≥ 40

≥ 40

> 250

> 150

Warp/weft dry

N

≥ 20

≥ 20

> 200 / > 150

> 200 / > 150

Warp/weft wet

N

≥ 20

≥ 20

> 200 / > 150

> 200 / > 150

Cleanliness

Barrier against liquid penetration Purity Microbiological Particle matter (foreign fibres) Particle release

Stability

Bursting strength

Tear strength

Unit of measurement

Standard

Value (1)

m2 Pa/W

ISO 11092

< 6,0

103 m2 Pa/W

ISO 11092

>7

%

GORETM-Method Run-off-Test on the basis of ISO 9073-6

> 70

Biocompatibility

-

ISO 10993-5

biocompatible

Viral penetration(1)

-

ASTM F 1671-97 and ISO 16604

no penetration(1) (2)

g/m2

ISO 3801

145 ± 10

Application*

Other performance features Comfort (= breathability) Water vapour transmission resistance (Ret) Comfort (= thermal insulation) Heat transmission resistance (Rct)

Miscellaneaous

Liquid absorption

Weight per square metre

1) Values represent product quality in new condition 2) Values represent product at the end of life cycle (80 cycles) 3) Biological contamination before sterilization depends on validated process of the reprocessors 4) Based on Gore laboratory process 5) Depends on validated process of reprocessors 6) Test conducted at the laminate and the sealed seam at the sleeve *) Contained in the appendix to EN 13795 GORETM, GORETM Comfortable Liquid Proof Fabric (CLIP) und Bildzeichen sind Marken von W.L. Gore & Associates. © W.L. Gore & Associates GmbH, 2008. Printed in Germany. D1230. TESB7027L02.

Materials for touching

GORE™ CLIP

SIOMED Mikrofaser

SIOMED – microfilament in the less critical area For the less critical area and for Standard Performance OR gowns, surgical solutions® OR-System uses SIOMED as performing and highly breathable microfiber, developed and produced by SIOEN. Grip, handling and performance of SIOMED offer an convincing and harmonic completion to the CLIP laminate in the less critical area. i Produktkatalog i

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System Surgical Solutions

Dedicated to the norms

Permanent high performance

Modern reusable materials represent the right

Due to the fact that reusable textiles are used over

solution for medical products in the light of

a long product life cycle, all fabrics of the surgical

hygiene, safety, economy and ecology.

solutions® System do have a quality in new

In Europe the sterile OR-drape and gown system

condition which is much above the requirements

surgical solutions , made out of textile Medical

defined in the EN 13795. The high-quality GORE™-

products, is based on the Quality Management

laminates and SIOMED microfilaments fulfill all

System DIN EN ISO 9001:2008 and

requirements of the modern surgery with regards

DIN EN ISO13485:2003 + AC:2007.

to norm conformity, safety, hygiene, Handling and

The conformity for the medical use of the

comfort.

®

surgical solutions®- OR-system is documented

with the CE label. For all recommendations for

Safe reprocessing of textile Medical Products

hospital hygiene in Germany the guide line of the

EN 13795 specifies validated processes for the

RKI (Robert-Koch-Institute) plays an important role

manufacturing and reprocessing. All textiles of the

or in other countries similar guidelines from other

surgical solutions®-OR- System pass through with

institutes. As microorganism can be transported

each cycle especially aligned process steps, which

with liquids, all guidelines position the demands to

are continuously monitored and controlled by the

hygiene during surgeries into the highest category.

quality management system. For the registration and

Here they all require resistant products with a high

control of microbiological risks specific requirements

barrier against liquid penetration.

are defined, e.g. RAL GZ 992/2 for Germany and

These recommendations are also followed by the

for Europe Hygiene Management Systems like the

European norm for OR gowns and drapes, the so

RABC-System (Risk Analysis Biocontamination

called DIN EN 13795. Reusable OR textiles of the

Control) which is described in the EN 14065.

surgical solutions -system fulfill and outperform

These kinds of regulations and normative

the criteria set in this norm and strongly contribute to

requirements give a good orientation for other new

an effective infection prophylaxis in the OR.

markets using surgical solutions®-OR- System

All used materials avoid a transfer of infective

in the future, and will help to set up the right

agents during all surgical procedures and offer

environment for a successful use of the reusable

a safe protection for the patient and the OR team.

surgical solutions®-OR- System.

®

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i Produktkatalog


Chances for the environment

Economical importance

The especially for re-use and reprocessing

Production, reprocessing and supply of the surgical

developed and tailored materials of the surgical

solutions速-System is bounded in a qualified

solutions速-System assure a sustainable and

textile full service supply into the hospitals. The

reasonable exposure with valuable resources. Many

service is mainly generated locally and regionally by

studies and life cycle assessments have pointed out

medium sized Textile Service companies or hospital

the preference of production of re-usable products

laundries. Hence, the value added, on the contrary to

and its gentle reprocessing. (SAFEC Study 2001,

disposable products, mainly takes place in the home

ETSA life cycle assessment for OR gowns 2003,

country and has therefore a much bigger economic

Evaluation of OR-textiles, TU Dresden 2009, Life

relevance. Laundries have developed themselves to

cycle assessment reusable versus disposables,

producers of Medical Products and reached a high

RMIT university, Australia)

competence- and value added level.

Value added chain

LAUNDRY

OR 1

R et u r n

2 1 WASHING MACHINE

3

2 DRYER 3 INSPECTION 4 DURABLE REPAIR

(IF NECESSARY)

5 ADEQUATE

FUNCTIONAL FOLDING

4

6 STERILIZATION

5

Ne e ds 6

pl s up

y

RAW MATERIALS

based just-in-time

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System Surgical Solutions

Application-oriented solutions – comprehensive consultancy The intelligent confection of the used articles

today’s tight staff situation or for ambulant surgery.

simplifies the process of draping in the OR, and

surgical solutions® convinces the end-user

provides the OR-team with operative safety.

in their daily practice. The system is based on a

surgical solutions®-OR System will completely

standardized, clearly arranged number of articles of

fulfill all individual requirements of the OR team to

single drape- and gown components. On customer

set up of the sterile field around the incision area.

demand all single components can be configurated

Self adhesive drapes, flexible and latex free inserts

to indication related sets or the end user selects one

with different shapes and end user oriented folding

of the standard set of the surgical solutions®-

techniques provide a safe fixation and fast de

OR-System. Consultants for Medical Devices advice

folding of the drapes. surgical solutions OR-

the customer about application-oriented solutions

System also offers modern one-drape systems in

and an individual process organization.

®

order to save time during the draping process. The system is in nearly all cases capable to be draped by only one person, which is a big advantage in

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i Produktkatalog


5 Acessories

4 Surgical drapes

3 Hole drapes

2

Slit drapes

1 OR gowns

Artikel overview system surgical solutions

No.

Article Code

1

217

OR gown SP “Large”

140 cm

Standard Performance

2

297

OR gown SP “Small”

130 cm

Standard Performance

3

917

OR gown HP “Small”

130 cm

High Performance

4

927

OR gown HP “Large”

140 cm

High Performance

5

937

OR gown HP “Extra large”

145 cm

High Performance

6

100

Hole slit drape

67 x 67 cm

High Performance

7

102

Poly slit hole drape

107 x 147 cm

High Performance

8

111

U-drape

252 x 247 cm

High Performance

9

128

Cardiology-double slit drape

353 x 200 cm

High Performance

10

129

U-drape struma

167 x 280 cm

High Performance

11

131

U-drape vascular

197 x 280 cm

High Performance

12

134

Slit drape

355 x 219 cm

High Performance

13

141

Pedriatic U-drape

194 x 185 cm

High Performance

14

163

U-drape

131 x 208 cm

High Performance

15

169

Lap-drape

257 x 243 cm

High Performance

16

216

Slit drape

144 x 110 cm

Standard Performance

17

219

Slit drape

200 x 144 cm

Standard Performance

18

108

Extremity drape

352 x 283 cm

High Performance

19

110

Vaginal drape

226 x 231 cm

High Performance

20

112

Hole drape

50 x 67 cm

High Performance

21

133

Eye drape

100 x 136 cm

High Performance

22

151

TUR drape

227 x 232,5 cm

High Performance

23

159

Extremity drape

308 x 389 cm

High Performance

24

160

Rhomb drape

150 x 110 cm

High Performance

25

168

Abdominal drape

352 x 299 cm

High Performance

26

197

Cardiology hole drape

320 x 158 cm

High Performance

27

103

Side drape

68 x 110 cm

High Performance

28

104

Side drape

92 x 139 cm

High Performance

29

106

Surgical drape

147 x 208 cm

High Performance

30

115

Surgical drape

67 x 88 cm

High Performance

31

116

Anesthesia drape

162 x 284 cm

High Performance

32

142

Pubic drape

20 x 44 cm

High Performance

33

143

Pedriatic anesthesia drape

145 x 259 cm

High Performance

34

146

Surgical drape

206 x 178 cm

High Performance

35

181

Cardiology leg drape

279 x 232 cm

High Performance

36

1862

Cardiology anesthesia drape

195 x 271 cm

High Performance

37

191

Leg drape

195 x 208 cm

High Performance

38

200

Surgical drape

70 x 70 cm

Standard Performance

39

203

Surgical drape

88 x 146 cm

Standard Performance

40

204

Surgical drape

69 x 117 cm

Standard Performance

41

205

Basic drape

200 x 145 cm

Standard Performance

42

246

Functional drape

200 x 145 cm

Standard Performance

43

125

Stockinet M

61 x 30 cm

High Performance

44

126

Stockinet L

88 x 32 cm

High Performance

45

127

Stockinet XL

111 x 36 cm

High Performance

46

130

Stockinet XXL

126 x 38 cm

High Performance

47

137

Sleeve cuff

27 x 58 cm

High Performance

48

167

Cardiology bag

40 x 42 cm

High Performance

49

194

Mayo table cover

164 x 79 cm

High Performance

50

230

Leg bag

129 x 73 cm

Standard Performance

51

231

Stockinet S

41 x 26 cm

Standard Performance

52

232

Stockinet M

71 x 41 cm

Standard Performance

53

244

Shoot

133 x 115 cm

Standard Performance

54

268

Dia bag

40 x 36 cm

Standard Performance

55

286

Stool cover

50 x 48 cm

Standard Performance

56

288

Radiograph hood

170 x 100 cm

Standard Performance

57

409

Functional drape

76 x 86 cm

No categorie

Description

Measures

Performance class

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SIOEN HEAD OFFICE

Fabriekstraat 23 • B-8850 Ardooie - Belgium Phone: +32 (0)51 740 800 • Fax: +32 (0)51 740 962 (&-963) E-mail: customer@sioen.be

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