A world of choice in silicone tubing and fluid handling products

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®
A world of choice in
silicone tubing and
fluid handling products
Platinum-cured USP Class VI
ISO 13485 Certified
ISO 14644 Certified
ISO Class 7 and 8 Cleanrooms
FDA Registered
SILICONE TUBING
SILICONE STOPPERS
SILICONE GASKETS
CUSTOM SERVICES
®
Delivering quality silicone
tubing and fluid handling
products on time, on spec,
and on budget
The world’s leading pharmaceutical and
medical device companies rely on HelixMark to
deliver an extensive selection of high-quality
silicone tubing and fluid handling products.
Manufactured globally by Helix Medical,
HelixMark products are available off-the-shelf
in a wide array of product types and sizes. We
also offer a broad range of silicones from all the
major manufacturers.
Best of all, we deliver all our products on time,
on spec, and on budget.
•PharmaFocus® Tubing
• Standard Tubing
• Braided Reinforced Tubing
• Color Stripe Tubing
• Close Tolerance Tubing
• Peristaltic Pump Tubing
•Stoppers
•Gaskets
• Custom Back-jacketed Tubing
• Custom Assemblies
• Custom Packaging
THE CHOICE OF SILICONE
YOU WANT
HelixMark products are available with a choice of
pharmaceutical- and medical-grade silicones
made by industry leaders including Dow Corning,
Wacker, NuSil, and Momentive. Blue Star is also
available for custom applications.
THE CUSTOM SERVICES
YOU DESERVE
Custom ID/OD sizing, custom labeling and
certification, and a variety of packaging formats are
available including bulk, spooled, and cut-to-length.
Additional custom services include skiving, pad printing,
bonding/gluing, punching, drilling, parylene coating,
proprietary striping, and rapiopaque. Helix Medical offers
custom extrusions in a wide variety of tubing types
including multi-lumen, intricate cross sections, co-extrusion,
wire coating, profiles, rods, tapes, and formed tubing.
THE QUALITY STANDARDS
YOU DEMAND
HelixMark products have been developed as a result of over 28 years
of medical device manufacturing experience. We apply an ISO 13485
medical device quality system to all production and inspection processes
and include material certification and lot traceability with every product.
Our products are fabricated in an FDA-registered facility with ISO 14644 Class 7
and 8 cleanrooms (USP Class VI, ISO 10993).
PharmaFocus® Tubing
Focused
on quality
THE RIGHT TESTING
The platinum-cured silicone elastomer used for
our PharmaFocus Tubing has been designed
specifically to fit the needs of the pharmaceutical
marketplace. This silicone undergoes a battery
of biocompatibility tests appropriate for
pharmaceutical applications, eliminating the costly
extended implant studies typically performed on
biomedical-grade silicones. The result: a more costeffective silicone tubing that delivers consistent
quality and the right level of assurance.
THE RIGHT SOURCE
Helix Medical consistently strives to meet our
number one goal: to instill confidence into every
product we make. This drive to provide peak levels
of assurance to our customers compels us to meet
the highest standards available for our production
areas.
PharmaFocus Platinum-cured Silicone Tubing is
available in 11 popular size combinations.
Typical hardness: 50 Shore A.
INSIDE
DIAMETER
inch
OUTSIDE
DIAMETER
mm
WALL
mm
ref number
.1253.18
.2506.35
.0631.59
61-252-21
.1884.76
.3137.94
.0631.59
61-252-22
.1884.76
.3759.53
.0942.38
61-252-23
.250 6.35
.43811.11
.094 2.38
61-252-25
.250 6.35
.50012.70
.125 3.18
61-252-26
.313 7.94
.50012.70
.094 2.38
61-252-27
.375 9.53
.62515.88
.125 3.18
61-252-30
.500
12.70.750
19.05.125
3.18
61-252-32
.625
15.88.875
22.23.125
3.18
61-252-33
.750 19.05
1.000 25.40
.125 3.18 61-252-35
1.000
25.40
1.50038.10
.250 6.35
61-252-36
inch
mm
inch
Values listed are typical. Please contact customer service for tolerances
and custom size requests.
PHARMAFOCUS TUBING RANGE SIZE INDICATOR
S PECI F I C AT I O NS
n
s
l
t
ISO 10993-I
FDA 21CFR 177-2600
USP Class VI
EP 3.1.9
50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant
boxes. • Material Certification and Lot Traceability included in every box.
Largest Size:
1.0 ID X 1.5 OD
Smallest Size:
.125 ID X .250 OD
(877) 308-0558 / helixmedical.com
1
Standard Silicone Tubing
Full range
of sizes,
wide choice
of silicones
HelixMark Standard Silicone Tubing is
offered in a full range of competitive
sizes in four choices of silicone
elastomer: Dow Corning, Wacker, NuSil,
or Momentive.
INSIDE
DIAMETER
inch
All of our HelixMark Standard Silicone
Tubing offerings are platinum-cured,
and contain no additives, plasticizers,
or peroxide components. The tubing
is nonadherent and resists clotting,
sticking, or encrustation. With the ability
to operate at elevated temperatures,
it will not oxidize or deteriorate.
Rigorous testing, including expanded
biocompatibility, provides quality
assurance for the most demanding
biomedical/pharmaceutical industry
standards. HelixMark Standard Tubing
can be sterilized with autoclave,
ethylene oxide, or gamma radiation
within the user’s validated cycles and
exposure levels.
STANDARD TUBING RANGE SIZE INDICATOR
Dow Corning
Silastic
OUTSIDE
DIAMETER
mm
inch
mm
WALL
inch
mm
Wacker
Nusil
n s l t
n s l
n lt
l s
ref number
ref number
ref number
ref number
Momentive
.012.31
.025.64
.006.15
60-011-01
60-411-40
60-795-01
60-805-01
.020.51
.037.94
.008.20
60-011-02
60-411-41
60-795-02
60-805-02
.025 .64
.0471.19
.011 .28
60-011-03
60-411-42
60-795-03
60-805-03
.030 .76
.0651.65
.018 .46
60-011-04
60-411-43
60-795-04
60-805-04
.040
1.02.085
2.16.023
.58
60-011-05
60-411-44
60-795-05
60-805-05
.058
1.47.077
1.96.009
.23
60-011-06
60-411-45
60-795-06
60-805-06
.062
1.58.095
2.41.016
.41
60-011-07
60-411-46
60-795-07
60-805-07
.062
1.58.125
3.18.032
.81
60-011-08
60-411-47
60-795-08
60-805-08
.078
1.98.125
3.18.024
.61
60-011-09
60-411-48
60-795-09
60-805-09
.1042.64
.0441.12
60-011-10
60-411-49
60-795-10
60-805-10
.132
3.35.183
4.65.026
.66
60-011-11
60-411-50
60-795-11
60-805-11
.1253.18
.2506.35
.0631.59
60-011-21
60-411-51
60-795-21
60-805-21
.1884.76
.3137.94
.0631.59
60-011-22
60-411-52
60-795-22
60-805-22
.1884.76
.3759.53
.0942.38
60-011-23
60-411-53
60-795-23
60-805-23
.2506.35
.3759.53
.0631.59
60-011-24
60-411-54
60-795-24
60-805-24
.250 6.35
.43811.11
.094 2.38
60-011-25
60-411-55
60-795-25
60-805-25
.250 6.35
.50012.70
.125 3.18
60-011-26
60-411-56
60-795-26
60-805-26
.313 7.94
.50012.70
.094 2.38
60-011-27
60-411-57
60-795-27
60-805-27
.375 9.53
.50012.70
.063 1.59
60-011-28
60-411-58
60-795-28
60-805-28
.375 9.53
.56314.29
.094 2.38
60-011-29
60-411-59
60-795-29
60-805-29
.375 9.53
.62515.88
.125 3.18
60-011-30
60-411-60
60-795-30
60-805-30
.500
12.70.688
17.46.094
2.38
60-011-31
60-411-61
60-795-31
60-805-31
.500
12.70.750
19.05.125
3.18
60-011-32
60-411-62
60-795-32
60-805-32
.625
15.88.875
22.23.125
3.18
60-011-33
60-411-63
60-795-33
60-805-33
.625
15.88.938
23.82.156
3.97
60-011-34
60-411-64
60-795-34
60-805-34
N/A
60-411-65
N/A
N/A
.750 19.05
.1924.88
1.00025.40
.125 3.18
TYPICAL PROPERTIES AS CURED
Specific Gravity
Durometer Hardness, Shore A pts
Tear Strength, Die B, ppi
Tensile Strength, Die C, psi
Elongation, Percent
1.161.15 1.141.15
50
55
50
52
262
218
230
270
1473
1385
1350
1400
903771 810880
Please contact customer service for tolerances and custom size requests. Specification Writers: Values stated are typical values only and
are not intended for use in preparing specifications.
Largest Size:
.750 ID X 1.0 OD
Smallest Size:
.012 ID X .025 OD
S PECI F I C AT I O NS
n
ISO 10993-I
s
FDA 21CFR 177-2600
l
USP Class VI
50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant
boxes. • Material Certification and Lot Traceability included in every box.
2
t
EP 3.1.9
Color Stripe Tubing
Recognize
lines at
a glance
HelixMark Color Stripe Silicone Tubing
is available with three choices of color
striping: red, green, or white. Whether
you want to recognize your lines at a
glance by application, tubing size, or
functional area, HelixMark Color Stripe
Tubing gives you the flexibility to create
your own system. Add nonstripe
and custom colors to create as complex
a system as necessary. Typical
Hardness: 55 Shore A.
INSIDE
DIAMETER
inch
mm
OUTSIDE
DIAMETER
inch
mm
WALL
inch
mm
Red
Stripe
ref number
Green
Stripe
ref number
White
Stripe
ref number
.1253.18
.2506.35
.0631.59
61-078-21
61-079-21
61-080-21
.1884.76
.3759.53
.0942.38
61-078-23
61-079-23
61-080-23
.250 6.35
.50012.70
.125 3.18
61-078-26
61-079-26
61-080-26
.313 7.94
.50012.70
.094 2.38
61-078-27
61-079-27
61-080-27
.375 9.53
.62515.88
.125 3.18
61-078-30
61-079-30
61-080-30
.500
12.70.750
19.05.125
3.18
61-078-32
61-079-32
61-080-32
Values listed are typical. Please contact customer service for tolerances and custom size requests.
COLOR STRIPE TUBING RANGE SIZE INDICATOR
Our proprietary process
ensures that the silicone
stripe is integrated into
the tube wall, yet does
not touch the inner bore.
Largest Size:
.500 ID X .750 OD
Smallest Size:
.125 ID X .250 OD
S PECI F I C AT I O NS
n
s
l
ISO 10993-I
FDA 21CFR 177-2600
USP Class VI
50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant
boxes. • Material Certification and Lot Traceability included in every box.
(877) 308-0558 / helixmedical.com
®
3
Braided Reinforced Tubing
Close Tolerance Tubing
Ideal for
increased
pressure or high
temperatures
Superior flow
for exacting
applications
Manufactured with our proprietary process
incorporating strong polyester braiding between
extrusions of platinum-cured silicone, our durable
Braided Reinforced Tubing with the identifiable blue
spiral is ideally suited for increased pressure and/
or high-temperature applications. HelixMark Braided
Reinforced Tubing can be sterilized by autoclave,
ethylene oxide, or gamma radiation within the user’s
validated cycles and exposure levels.
Typical hardness: 65 Shore A.
INSIDE
DIAMETER
inch
mm
OUTSIDE
DIAMETER
inch
mm
Biomedical/pharmaceutical-grade platinum-cured
silicone tubing, manufactured with Dow Corning,
provides superior flow properties. HelixMark close
tolerance silicone tubing ensures minimal dimension
variation, making this tubing appropriate for exacting
applications. It can be sterilized with autoclave or
ethylene oxide as well as by gamma radiation within
the user’s validated cycles and exposure levels.
Typical hardness: 50 Shore A.
MINIMUM
BURST @ 70° F
INSIDE
DIAMETER
PSI
ref number
inch
inch
mm
WALL
inch
mm
ref number
.1253.18
.3659.27
705
60-664-20
.1253.18
.2506.35
.0631.59
60-111-21
.187
4.76
.447
11.35
655
60-664-30
.1884.76
.3137.94
.0631.59
60-111-22
.250
6.35
.520
13.21
630
60-664-40
.2506.35
.3759.53
.0631.59
60-111-24
.312
7.93
.592
15.04
555
60-664-45
.2506.35
.43811.13
.0942.38
60-111-25
.375
9.53
.655
16.64
505
60-664-50
.3759.53
.56314.29
.0942.38
60-111-29
.500
12.70
.800
20.32
430
60-664-60
.3759.53
.62515.88
.1253.18
60-111-30
.625
15.88
.965
24.51
355
60-664-70
.50012.70
.68817.46
.0942.38
60-111-31
.750
19.05
1.100
27.94
280
60-664-80
.50012.70
.75019.05
.1253.18
60-111-32
.875
22.23
1.235
31.37
255
60-664-90
.62515.88
.87522.23
.1253.18
60-111-33
1.000
25.40
1.360
34.54
230
60-664-100
Values listed are typical. Please contact customer service for tolerances and custom size
requests.
Values listed are typical. Please contact customer service for tolerances and custom
size requests.
S P E C I F I C AT I O N S
S P E C I F I C AT I O N S
n
s
l
t
ISO 10993-I
n
ISO 10993-I
FDA 21CFR 177-2600
s
l
t
USP Class VI
USP Class VI
EP 3.1.9
25 Foot Coils (7.62 meters) • Packaged double bagged in crush-resistant
boxes. • Material Certification and Lot Traceability included in every box.
4
mm
OUTSIDE
DIAMETER
FDA 21CFR 177-2600
EP 3.1.9
50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant
boxes. • Material Certification and Lot Traceability included in every box.
Peristaltic Pump Tubing
Longer life,
superior strength,
proven performance
HelixMark Peristaltic Pump Tubing, manufactured with Wacker
Silicones material, meets the strength and durability required
for pump applications. Peristaltic Pump Tubing undergoes
Helix’s special stabilization process, providing the additional
benefits of superior strength, performance, and longer
life. Our tubing offers proven longer wear and volumetric
consistency over 8, 12, and 24 hour process runs and is the
most reliable and consistent platinum-cured silicone tubing
available today for pumping applications. Typical hardness:
60 Shore A.
PUMPING CONSIDERATIONS AND PRECAUTIONS
In pumping procedures, particularly those involving extracorporeal circuitry using a
roller head, these items should be considered:
1. U
nder certain conditions, microscopic particles (spallation) can be generated with
any pump head tubing. In-line filtration is highly recommended; if not feasible,
further safety and efficacy testing should be conducted.
2. O
ver-occlusive settings should be avoided. Adjust pump head rollers with the pump
manufacturer’s recommended procedure.
3. Care should be taken to avoid cuts or nicks.
4. Tubing should not be twisted when placed in the raceway of the pump.
5. S
ilicone fluid or silicone grease should not be used to lubricate silicone tubing as
these may swell and weaken the tubing.
6. R
outine maintenance is recommended for roller bearings. Tests have demonstrated
that improperly maintained rollers can cause increased drag and spallation.
Caution: In roller pump applications, the use of nominal tolerance tubing is not
recommended. If the total occlusive setting of the head exceeds the actual combined
wall thickness of the tubing, close tolerance wall tubing is recommended. The
information and data contained herein are based on information we believe reliable.
You should thoroughly test any application and independently conclude satisfactory
performance before use.
PERISTALTIC PUMP TUBING
RANGE SIZE INDICATOR
S P E C I F I C AT I O N S
n
s
l
ISO 10993-I
FDA 21CFR 177-2600
USP Class VI
25 Foot Coils (7.62 meters) • Packaged double
bagged in crush-resistant boxes. • Material
Certification and Lot Traceability included in
every box.
(877) 308-0558 / helixmedical.com
INSIDE
DIAMETER
inch
mm
DIAMETER
inch
mm
WALL
inch
mm
.0200.51 .1463.71 .0631.60
.0310.79 .1573.99 .0631.60
.0390.99 .0631.60 .0120.31
.0591.50 .0992.52 .0200.51
.0631.60 .1894.80 .0631.60
.0631.60 .2516.38 .0942.39
.0792.01 .1193.02 .0200.51
.0992.52 .1393.53 .0200.51
.1183.00 .1584.01 .0200.51
.1253.18 .2516.38 .0631.60
.1253.18 .3137.95 .0942.39
.1584.01 .2145.44 .0280.71
.1884.78 .3147.98 .0631.60
.1884.78 .3769.55 .0942.39
.1884.78 .3889.86 .1002.54
.188 4.78
.43811.13 .125 3.18
.2506.35 .3769.55 .0631.60
.250 6.35
.43811.13 .094 2.39
.250 6.35
.45011.43 .100 2.54
.250 6.35
.50012.70 .125 3.18
.250 6.35
.52013.21 .135 3.43
.313 7.95
.43911.15 .063 1.60
.313 7.95
.50112.73 .094 2.39
.313 7.95
.62915.98 .158 4.01
.3759.53 .56314.3 .0942.39
.375 9.53
.62515.88 .125 3.18
.375 9.53
.64516.38 .135 3.43
.375 9.53
.74919.03 .187 4.75
.473
12.01.789
20.03.158
4.01
.500
12.70.750
19.05.125
3.18
.500
12.70.770
19.56.135
3.43
.500
12.70.874
22.20.187
4.75
.625
15.88.875
22.23.125
3.18
.625
15.88.999
25.38.187
4.75
.630
16.00.946
24.03.158
4.01
.750 19.05 1.12428.55
.187 4.75
1.00025.40
1.374 34.90
.187 4.75
1.00025.40
1.400 35.56
.200 5.08
Values listed are typical. Please contact customer service
for tolerances and custom size requests.
Largest Size:
.750 ID X 1.0 OD
Fits Pump
Tube Size
ref number
#11260-825-15
#1360-825-23
60-825-27
60-825-37
#1460-825-43
#11960-825-45
60-825-51
60-825-63
60-825-70
#1660-825-79
#12060-825-82
60-825-93
#2560-825-104
#1560-825-108
#15TW60-825-110
#12360-825-112
#1760-825-130
#2460-825-133
#24TW60-825-136
#2660-825-139
#26TW60-825-141
#1860-825-160
#35/12160-825-163
#18560-825-166
#36/12260-825-191
#7360-825-194
#73TW60-825-197
#70/19060-825-200
#18660-825-230
#8260-825-243
#82TW60-825-245
#8860-825-248
#18460-825-262
#18960-825-270
#18760-825-288
#19160-825-310
#9260-825-420
#92TW60-825-428
TW = Thick Wall (variance between
competition pump numbers)
Smallest Size:
.020 ID X .146 OD
®
5
Silicone Stoppers
Silicone Clamp Gaskets
For tight,
reliable seals
Crevice-free,
protrusionfree, and
biocompatible
Pharmaceutical-grade Silicone Stoppers are ideal
for a tight, reliable seal when used with glass tubes,
vials, and flasks. These platinum-cured silicone
stoppers have full traceability to raw materials,
contain no peroxide catalysts, and are autoclavable.
Available in 14 standard sizes.
Please contact customer service with inquiries about
stoppers with pre-drilled holes.
STOPPER
SIZE
TOP
DIAMETER
BOTTOM
DIAMETER
Biomedical/pharmaceutical-grade Silicone Gaskets
are made with our proprietary molding process and
engineered geometry to promote crevice-free and
protrusion-free processing. The gaskets have
exceptional biocompatibility and contain no
contaminants or leachables. Clamp gaskets are
sterilizable by autoclave, ethylene oxide, or gamma
radiation within the user’s validated cycles and
exposure levels.
HEIGHT
TYPE
INSIDE
DIAMETER
inch
mm
ref number
Mini
0.5 12.70
70-400-05
Mini
0.75 19.05
70-400-07
Standard
1.0 25.40
70-400-10
70-416-01
Standard
1.5 38.10
70-400-15
.98425
70-416-02
Standard
2.0 50.80
70-400-20
.945 24 .709 18
.98425
70-416-03
Standard
2.5 63.50
70-400-25
4
1.02426
.787 20
.984 25
70-416-04
Standard
3.0 76.20
70-400-30
5
1.06327
.906 23
.984 25
70-416-05
Standard
4.0 101.60
70-400-40
6
1.26032 1.18130
.984 25
70-416-06
Standard
6.0 152.40
70-400-60
7
1.45737 1.18130
.984 25
70-416-07
Values listed are typical. Please contact customer service for tolerances and for custom size requests.
8
1.61441 1.29933
.984 25
70-416-08
9
1.77245 1.45737
.984 25
70-416-09
10
1.96950 1.65442
.984 25
70-416-10
12
2.52064 2.12654
.984 25
70-416-12
inch
mm
inch
mm
inch
mm
ref number
000
.512 13 .315 8
.98425
70-416-99
00
.591 15 .394 10
.98425
70-416-90
0
.669 17 .512 13
.98425
70-416-00
1
.748 19 .551 14
.98425
2
.787 20 .630 16
3
Values listed are typical. Please contact customer service for tolerances and custom size requests.
S P E C I F I C AT I O N S
S P E C I F I C AT I O N S
n
s
l
t
n
s
l
t
ISO 10993-I
FDA 21CFR 177-2600
USP Class VI
EP 3.1.9
Packaged 12 per zip bag in crush-resistant boxes.
Material Certification and Lot Traceability included
in every box.
6
INSIDE
DIAMETER
ISO 10993-I
FDA 21CFR 177-2600
USP Class VI
EP 3.1.9
Packaged 25 per zip bag in crush-resistant boxes.
Material Certification and Lot Traceability included
in every box.
Custom Services
Excellence
is customary
CUSTOM ASSEMBLIES
Dedicated to saving time
Utilize Helix Medical’s dedicated assembly expertise to free up valuable employee time.
Combine tubing, stoppers, and gaskets with complementary parts such as barbed tubing
connectors, tri-clamp compatible fittings, or luer adapters. Options can include full preassembly or simply component inclusion. Please contact our sales department for a quote.
CUSTOM BLACK-JACKETED TUBING
CUSTOM PACKAGING
For photosensitive drugs and light-sensitive fluids
A full array of options
Black-jacketed tubing is a custom extrusion offered
by Helix Medical. The tubing is manufactured to your
exact specifications (ID/OD sizing and packaging
format) and contains an opaque exterior layer to
block all light, so it’s ideal for photosensitive drugs or
light-sensitive fluids. The pigmented silicone exterior
does not touch the fluid path. Black-jacketed Tubing
is available with a choice of Dow Corning, Wacker,
Nusil, Momentive, or Blue Star USP Class VI silicones.
Material certification and lot traceability included in
every package.
Whether you want to reduce bag and box waste or
eliminate timely cutting of tubing to specified lengths,
Helix Medical can accommodate your needs. Consider our
array of alternative packaging options, including:
(877) 308-0558 / helixmedical.com
• S
pooling (amount on spool determined by tubing
outside diameter)
• Bulk coil packaging (multiple standard coils in each box)
• P
re-cut lengths (as short as mere fractions of an inch to
many feet, cut to your specified tolerance)
Please contact our sales department for a quote.
®
7
Technical Specifications
Terms & Conditions of Sale
QUALIFICATION/TECHNICAL SUPPORT
Any customer wishing to fully evaluate the cost/performance advantages
of Helix Medical products is encouraged to contact our friendly and
helpful customer service representatives at (800) 266-4421. We will
gladly furnish interested parties with documentation, samples and the
required technical support to assist in the qualification of our materials.
PAYMENT TERMS/FREIGHT POLICY
Payment is Net 30 days from date of invoice. VISA, Mastercard, and American
Express also accepted. All shipments are FOB plant/distribution center.
INDICATIONS FOR USE
Caution: The materials which comprise the HelixMark product lines are
not certified by the FDA for implant devices and are not intended to
be used in medical applications involving permanent implantation or
permanent contact with body fluids and tissues within the human body.
Failure to comply with this may lead to serious bodily injury or death.
Important: It is the user’s responsibility to ensure the suitability and
safety of HelixMark products for all intended uses, including the
verification of compatibility of any fluids or chemicals that may be
used with, or come into contact with, HelixMark products. The user
is responsible for conducting the appropriate testing in accordance
with the applicable requirements in order to determine the safety
and effectiveness for use in their desired applications. If intended for
medical use, the user is responsible for ensuring that the HelixMark
products that have been identified for use comply with all applicable
medical regulatory requirements.
CLEANING
Silicone tubing may be cleaned in a solution of hot water and mild soap.
Synthetic detergents or oil-based soaps should not be used as they may
be absorbed and subsequently leached out into transported fluids. If
it is necessary to use a brush, only a soft bristle one should be used.
Rinse thoroughly in purified (distilled) water, taking care to flush the
lumen of the tubing. Autoclave before the interior becomes dry. It is
important that moisture be present on the inside of the tubes to avoid
air locks during autoclaving.
STERILIZATION
Steam: HelixMark manufactured medical grade silicone tubing is able
to withstand all common steam autoclave sterilization cycles without
adverse effects to the tubing. Autoclave cycles should be qualified by
the user to their product configuration prior to sterilization. Ethylene
Oxide (EtO): The tubing is sterilized by normal EtO cycles that have
been qualified by the user; aeration times must also be set by the user
in accordance with product configuration. Dry Heat: Any usual dry heat
sterilization method, qualified by the user, also may be used to sterilize
the silicone tubing. Radiation: Silicone has been shown to withstand
gamma radiation sterilization within the usual exposure levels qualified
by the user. Some physical properties may be slightly changed as a
result of this form of sterilization. Effects that have been sometimes
seen include: Tensile strength remains essentially unchanged; Minimal
but measurable increase seen in durometer and tensile modulus at
200% elongation; Tear strength (Die B) and elongation may be slightly
decreased.
CUSTOMER SERVICE/ORDERS
USA and Canada
Toll Free Tel: (800) 266-4421, Monday — Friday, 8am to 5pm, Pacific Time
Customer Service E-mail: customerservice@helixmedical.com
Sales Inquiries E-mail: info@helixmedical.com
FAX: (805) 684-1934
INTERNATIONAL
Tel: (+1) 805 684-3304, Monday — Friday, 8am to 5pm, Pacific Time
Customer Service E-mail: customerservice@helixmedical.com
Sales Inquiries E-mail: info@helixmedical.com
FAX: (+1) 805 684-1934
TAXES
All prices are exclusive of sales, use, occupational, excise, income or
similar taxes and charges. Any such taxes and charges, wherever levied and
whenever imposed, shall be paid by the Buyer.
CANCELLED ORDERS
Cancellation of fabricated or custom-made orders will be subjected to a
cancellation fee. The cancellation fee will be determined by the amount of
tooling and production work done at the time of the cancellation. Any changes
to the order must be completed more than 30 days prior to dock date.
RETURNS
No product will be accepted for return after 30 days from date of shipment.
Goods must be in “as sold” condition. To return merchandise, please
contact our customer service department at (800) 266-4421 for a Return
Material Authorization (RMA) number. All returns must be authorized by
Helix Medical, no returns will be accepted without an RMA number. Any
merchandise accepted for credit will be subject to a 25% restocking charge.
To insure you receive credit, you must include with each return:
•Your name, address and purchase order number.
•Helix Medical shipping order number, date of invoice, and catalog
number(s).
•Your Return Material Authorization (RMA) number and your reason
for the return.
We cannot accept for return any of the following:
•Product provided by Helix Medical on a “Special Order.”
•Discontinued products.
•Product that has exceeded the 30 days return time-frame.
DAMAGED SHIPMENTS/DISCREPANCIES
Please inspect your shipment upon receipt. If it shows any external damage,
accept it only after the driver has noted the damage on both his and your
copies of the delivery receipt and you have requested an inspection by the
carrier. If, upon opening a shipment, you find a shortage or damage, you
must request inspection by the carrier within 15 days of delivery or you will
relinquish your right to make a claim. Any claims for shipment discrepancies
must be made within one week of receipt. Please contact our customer
service department at (800) 266-4421 to report a claim.
LIMITED WARRANTY
Products are warranted to be free from defects in material and workmanship.
Helix Medical’s entire liability and Buyer’s exclusive remedy shall be limited
to the replacement of or credit for defective products, as determined by
Helix Medical.
DISCLAIMER OF WARRANTY AND LIABILITY
Helix Medical, LLC disclaims all other warranties or guarantees with respect
to any products purchased from Helix Medical, LLC, whether statutory,
written, oral, express or implied, including, without limitation, any warranty
of merchantability, suitability or fitness for a particular purchase. In no event
shall Helix Medical, LLC be liable or responsible for any exemplary, punitive,
special, indirect, incidental or consequential damages (including, but not
limited to loss of profits, use, or goodwill) of any kind whether based on
contract, tort (including negligence), strict liability, or any other theory or
form of action even if Helix Medical, LLC has been advised of the possibility
thereof. Helix Medical, LLC sole liability and customer’s sole remedy for any
claim relating to any products purchased from Helix Medical, LLC is as set
forth in the limited warranty.
GOVERNING LAW
The contract arising from acceptance of Helix Medical’s offer shall be
governed by the laws of the state of California.
(877) 308-0558 / helixmedical.com
8
®
Silicone Chemical Compatibilities
• Denotes NOT compatible with silicone
Acetaldehyde
Acetamide
Acetic acid, cold
• Acetic anhydride
• Acetone
Acetylene
• Acrylonitrile
Aliphatic hydrocarbon
solvents
Alum
Aluminum chloride
Aluminum salts
Aluminum sulphate
Ammonia gas, cold
Ammonia gas, hot
Ammonium hydroxide
Ammonium nitrate
Ammonium phosphate
Ammonium salts
Ammonium sulphate
• Amyl acetate
• Amyl alcohol
• Amyl borate
• Amyl chloride
• Amyl chloronaphthalene
• Amyl naphthalene
Aniline, cold
• Aniline hydrochloride
Aromatic hydrocarbons
• Asphalt
Barium chloride
Barium hydroxide
Barium salts
Beer
Beer wort
Beet sugar liquors
• Benzaldehyde
• Benzene
Benzoic acid
Bleaching liquors
Blood
Borax
Boric acid
• Brighteners,
electroplating
• Bromine
• Bromobenzene
• Butane
• Butyl acetate
Butyl alcohol
• Butraldehyde
Calcium bisulphide
Calcium chloride
Calcium hydroxide
Calcium hypochlorite
Calcium nitrate
Calcium salts
Cane sugar liquors
Carbitol
• Carbolic acid
Carbon dioxide
Carbon monoxide
• Carbon tetrachloride
Carbonic acid
Castor oil
Caustic soda up to 50%
• Chlorinated solvents
• Chlorine, dry
• Chlorine, wet
• Chlorobenzene
• Chlorobromomethane
• Chloroform
• Chloronaphthalene
• Chlorosulphonic acid
• Chlorotuluene
Chrome plating solutions
• Chromic acid
Citric acid
Coconut oil
Cod liver oil
Copper salts
Corn oil
• Creosote
• Creosote oil
• Cresols
• Cyclohexane
Detergent solutions
Dextrose
Diacetone alcohol
Diatomaceous slurry
• Dibutyl Carbitol
• Dibutyl phthalate
• Dichlorobenzene
• Diethyl ether
Diethylamine
Diethylene glycol
• Diisopropyl ether
Dimethyl formamide
Dioctyl phthalate
Dioxane
• Diphenyl ether
“Downtherm” fluids
• Esters
Ethanolamine
Ethers
Ethyl acetate
Ethyl acetoacetate
Ethyl alcohol
• Ethyl cellulose
• Ethyl chloride
Ethylene
• Ethylene chlorohydrin
Ethylene diamine
• Ethylene dichloride
Ethylene glycol
• Ethylene oxide
• Ethylene trichloride
• Fatty acids
Ferric chloride
Ferric salts
• Fluorobenzene
Formaldehyde
Formic acid
• Fuel oils
Fumaric acid
• Gasoline
Gelatine
Glucose
Glycerine
Glycols
Green sulphate liquor
• Halowax oil
Hexaldehyde
• Hexane
• Hydraulic oil
• Hydrazine
• Hydrobromic acid
• Hydrochloric acid, cold
• Hydrochloric acid, hot
Hydrocyanic acid
• Hydrofluoric acid, cold
• Hydrofluoric acid, hot
• Hydrofluorosilicic acid
• Hydrogen gas
Hydrogen peroxide
• Hydrogen sulphate, dry
• Hydrogen sulphate, wet
Isobutyl alcohol
• Isooctane
Isopropyl alchohol
• Isopropyl nitrate
• Kerosene
• Ketones
Lactic acid, cold
Lard
• Lead acetate
Lead nitrate
Linseed oil
• Lithium hydroxide 5%
• Lubricating oils
Lye solution
(KOH & NaOH)
Magnesium ammonium
sulphate
Magnesium chloride
Magnesium salts
Magnesium sulphate
Manganese salts
Melamine
Mercury
• Mesityl oxide
• Methane gas
Methyl alcohol (methanol)
Methyl bromide
• Methyl chloride
• Methyl
diphenyldiisocyanate
Methyl ethyl ketone
Methyl formate
• Methyl isobutyl ketone
Methyl methacrylate
• Methylene chloride
Milk
Mineral oils
• Monochlorobenzene
Mustard
• Naptha
• Napthalene
Natural gas
Nickel chloride
Nickel salts
• Nitric acid
Source: Rubber Products Handbook, Rubber Products Manufacturers Association
• Nitrobenzene
• Nitroethane
Nitrogen
• Nitrogen oxides
Oils, animal
• Oils, lubricating
• Oils, mineral
Oils, vegetable
• Oleic acid
Oxalic acid
Oxygen, cold
Ozone
• Paraffin
• Perchloric acid
Perchloroethylene
• Petrol
• Phenol
• Phosphoric acid
Phthalic acid
• Picric acid
Pinene
Potassium carbonate
Potassium chlorate
Potassium cyanide
Potassium dichromite
• Potassium hydroxide
Potassium iodide
Potassium nitrate
Potassium salts
Producer gas
• Propane
Propyl alcohol
• Pyridine
Pyrrole
Rubber latex
Sea water
Sewage
• Silicone oil
Silver nitrate
Soap solutions
Soda ash
Sodium bicarbonate
Sodium bisulphate
Sodium bisulphite
Sodium borate
Sodium chloride
Sodium cyanide
Sodium dichromate
Sodium hydroxide
Sodium hypochlorite
• Sodium nitrate
Sodium nitrite
Sodium perborate
• Sodium peroxide
• Sodium phosphates
Sodium silicate
Sodium sulphate
Sodium sulphide
Sodium sulphite
Sodium thiosulphate
Soybean oil
Stannic chloride
Stannous chloride
Stearic acid
• Stoddards solvent
• Styrene
Sulphur
• Sulphur chloride
Sulphur dioxide
Sulphur hexafluoride
Sulphur dioxide, dry
Sulphur trioxide, dry
• Sulphuric acid 10% cold
• Sulphuric acid 10% hot
• Sulphuric acid 10-75% cold
• Sulphuric acid 10-75% hot
• Sulphuric acid 75-95% cold
• Sulphuric acid 75-95% hot
• Sulphurous acid
Tannic acid
Tar
Tartaric acid
• Terpineol
Tertiary butyl catechol
• Tertiary butyl mercaptan
Thionyl chloride
Tin chlorides
• Toluene
• Trichlorethane
• Trichlorethylene
• Tricresyl phosphate
• Turpentine
Urea
Vegetable oils
Vinegar
Water
Water, fresh
Water, sea
Whisky
Wine
Wort
• Xylene
• Xylol
Yeast
®
You’ll Find Helix Medical All Around the World
Since 1984, Helix Medical has been a custom manufacturer for the world’s leading
medical device and healthcare companies.
Medical manufacturing capabilities include design and development, silicone and
thermoplastic molding and extrusion, complex catheter systems, component and
product assembly, packaging and labeling, and comprehensive engineering services.
We operate FDA-registered, ISO 13485 certified medical device facilities, with
Class 7 and 8 cleanrooms.
Helix Medical manufacturing locations are all around the world: California,
Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland and China.
A LEAN MANUFACTURING/SIX SIGMA PARTNER
Using Lean Manufacturing and Six Sigma Methodology, Helix Medical
delivers value-added solutions to reduce lead-times and maximize
efficiency. Some of the tools and methods include Kaizen, value stream
mapping, 3P, VA/VE, and dedicated Lean and Six Sigma management.
(877) 308-0558 / helixmedical.com
© 2015 Helix Medical, LLC – 150502
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