OR-gowns OR-drapes
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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
i Produktkatalog
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
i Produktkatalog i
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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
i Produktkatalog i
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