Orfit 24-5680-1 User Manual

TECHNICAL DATA SHEET
ORFIT® NS SOFT 1.6 mm (1/16”)
Thickness
mm (inches)
1.6 (1/16)
1.6 (1/16)
Perforation
% (type)
0 (non perfo)
13 (micro)
Optimum activation temperature (in water bath)
°C (°F) 65 (149)
65 (149)
Activation time (in water bath)
minutes
3 - 4
3 - 4
Transparent when activated
yes
yes
Working time
minutes
1 ¼ - 1 ¾
1 - 1 ½
Hardening time
minutes
3 ¾ - 4 ¼
2 ½ - 3
Time to completion
minutes
16 - 17
13 - 14
Resistance to stretch
moderate
moderate
Drape high
high
Memory (after 200 % elongation)
full
full
Maximum elongation when activated
%
1250
1050
Memory (after maximum elongation)
full
full
Sticks to itself when activated and wet
temporarily
temporarily
Sticks to itself when activated, after drying
temporarily
temporarily
Adhesion (velcro strip) using heat gun
No
no
Flexural modulus
MPa 530 380
Elastic modulus
MPa
300
265
Tensile strength
MPa
20.0
15.0
Strain at break
%
no break
60
Density g cm-³ 1.13 1.13
Hardness (shore D)
60
60
Surface feeling smooth
smooth
Color
skin
skin
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS SOFT 2.0 mm (1/12”)
Thickness
mm
(inches)
2.0
(1/12)
2.0
(1/12)
2.0
(1/12)
2.0
(1/12)
2.0
(1/12)
Perforation
%
(type)
0
(non perfo)
3.5
(mini)
13
(micro)
25
(maxi)
28
(micro+)
Optimum activation temperature (in water bath)
°C (°F)
65 (149)
65 (149)
65 (149)
65 (149)
65 (149)
Activation time (in water bath)
minutes
3 - 4
3 - 4
3 - 4
3 - 4
3 - 4
Transparent when activated
yes
yes
yes
yes
yes
Working time
minutes
1 ¼ - 1 ¾
1 - 1 ½
1 - 1 ½
1 - 1 ½
1 - 1 ½
Hardening time
minutes
6 - 6 ½
4 ½ - 5
3 - 3 ½
2 ½ - 3
2 ¾ - 3 ¼
Time to completion
minutes
29 - 30
18 - 19
14 - 15
13 - 14
10 - 11
Resistance to stretch
moderate
moderate
moderate
moderate
moderate
Drape high
high
high
high
high
Memory (after 200 % elongation)
full
full
full
full
full
Maximum elongation when activated
%
1350
1250
1150
1125
1050
Memory (after maximum elongation)
full
full
full
full
full
Sticks to itself when activated and wet
temporari
ly
temporaril
y
temporari
ly
temporaril
y
temporaril
y
Sticks to itself when activated, after drying
temporari
ly
temporaril
y
temporari
ly
temporaril
y
temporaril
y
Adhesion (velcro strip) using heat gun
no
no
no
no
no
Flexural modulus
MPa 530 530 370 300 325
Elastic modulus
MPa
300
230
265
170
240
Tensile strength
MPa
21.0
15.0
15.5
10.5
12.0
Strain at break
%
no break
90
50
no break
160
Density
g cm-³ 1.13 1.13 1.13 1.13 1.13
Hardness (shore D)
60
60
60
60
60
Surface feeling
smooth
smooth
smooth
smooth
smooth
Color skin
skin
skin
skin
skin
Odor none
none
none
none
none
Fatigue
cycles
> 10000
> 10000
> 10000
> 10000
> 10000
Biocompatible
yes
yes
yes
yes
yes
Thermoformin g conditions
Mechanical propert ies at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS SOFT 2.5 mm (3/32”)
Thickness
mm (inches)
2.5 (3/32)
Perforation
% (type)
13 (micro)
Optimum activation temperature (in water bath)
°C (°F) 65 (149)
Activation time (in water bath)
minutes
3 - 4
Transparent when activated
yes
Working time
minutes
1 ½ - 2
Hardening time
minutes
4 ½ - 5
Time to completion
minutes
23 - 24
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
full
Maximum elongation when activated
%
1275
Memory (after maximum elongation)
full
Sticks to itself when activated and wet
temporarily
Sticks to itself when activated, after drying
temporarily
Adhesion (velcro strip) using heat gun
no
Flexural modulus
MPa 440
Elastic modulus
MPa
250
Tensile strength
MPa
16.5
Strain at break % 37.0
Density g cm-³ 1.13
Hardness (shore D)
60
Surface feeling smooth
Color
skin
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS SOFT 3.2 mm (1/8”)
Thickness
mm (inches)
3.2 (1/8)
3.2 (1/8)
3.2 (1/8)
Perforation
% (type)
0 (non perfo)
3.5 (mini)
25 (maxi)
Optimum activation temperature (in water bath)
°C (°F)
65 (149)
65 (149)
65 (149)
Activation time (in water bath)
minutes
4 -5
4 -5
4 - 5
Transparent when activated
yes
yes
yes
Working time
minutes
2 - 2 ½
1 ¾ - 1 ¼
1 ¾ - 2 ¼
Hardening time
minutes
7 ½ - 8
6 ½ - 7
4 ¾ - 5 ¼
Time to completion
minutes
21 - 22
21 - 22
18 - 19
Resistance to stretch
moderate
moderate
moderate
Drape high
high
high
Memory (after 200 % elongation)
full
full
full
Maximum elongation when activated
%
1400
1575
1200
Memory (after maximum elongation)
full
full
full
Sticks to itself when activated and wet
temporarily
temporarily
temporarily
Sticks to itself when activated, after drying
temporarily
temporarily
temporarily
Adhesion (velcro strip) using heat gun
no
no
no
Flexural modulus
MPa 530 510 340
Elastic modulus
MPa
300
275
185
Tensile strength
MPa
22.5
16.5
11.5
Strain at break
%
290
105
270
Density g cm-³
1.13 1.13 1.13
Hardness (shore D)
60
60
60
Surface feeling
smooth
smooth
smooth
Color skin
skin
skin
Odor none
none
none
Fatigue
cycles
> 10000
> 10000
> 10000
Biocompatible
yes
yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS SOFT 4.2 mm (3/16”)
Thickness
mm (inches)
4.2 (3/16)
4.2 (3/16)
Perforation
% (type)
0 (non perfo)
3.5 (mini)
Optimum activation temperature (in water bath)
°C (°F) 65 (149)
65 (149)
Activation time (in water bath)
minutes
4 - 5
4 - 5
Transparent when activated
yes
yes
Working time
minutes
2 ½ - 3
2 ¼ - 2 ¾
Hardening time
minutes
9 - 9 ½
8 - 8 ½
Time to completion
minutes
28 - 29
24 - 25
Resistance to stretch
moderate
moderate
Drape high
high
Memory (after 200 % elongation)
full
full
Maximum elongation when activated
%
1425
1200
Memory (after maximum elongation)
full
full
Sticks to itself when activated and wet
temporarily
temporarily
Sticks to itself when activated, after drying
temporarily
temporarily
Adhesion (velcro strip) using heat gun
no
no
Flexural modulus
MPa 530 475
Elastic modulus
MPa
300
285
Tensile strength
MPa
21.5
17.0
Strain at break
%
no break
145
Density g cm-³ 1.13 1.13
Hardness (shore D)
60
60
Surface feeling smooth
smooth
Color
skin
skin
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS STIFF 3.2 mm (1/8”)
Thickness
mm (inches)
3.2 (1/8)
3.2 (1/8)
Perforation
% (type)
0 (non perfo)
3.5 (mini)
Optimum activation temperature (in water bath)
°C (°F) 65 (149)
65 (149)
Activation time (in water bath)
minutes
4 - 5
4 - 5
Transparent when activated
yes
yes
Working time
minutes
2 - 2 ½
1 ¾ - 2 ¼
Hardening time
minutes
7 ½ - 8
6 ½ - 7
Time to completion
minutes
21 - 22
24 - 25
Resistance to stretch
high
high
Drape high
high
Memory (after 200 % elongation)
full
full
Maximum elongation when activated
%
1150
1020
Memory (after maximum elongation)
full
full
Sticks to itself when activated and wet
temporarily
temporarily
Sticks to itself when activated, after drying
temporarily
temporarily
Adhesion (velcro strip) using heat gun
no
no
Flexural modulus
MPa 530 485
Elastic modulus
MPa
310
270
Tensile strength
MPa
20.0
16.5
Strain at break
%
no break
45
Density g cm-³ 1.13 1.13
Hardness (shore D)
60
60
Surface feeling smooth
smooth
Color
skin
skin
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
ORFIT® NS STIFF 4.2 mm (3/16”)
Thickness
mm (inches)
4.2 (3/16)
4.2 (3/16)
Perforation
% (type)
0 (non perfo)
3.5 (mini)
Optimum activation temperature (in water bath)
°C (°F) 65 (149)
65 (149)
Activation time (in water bath)
minutes
4 - 5
4 - 5
Transparent when activated
yes
yes
Working time
minutes
2 ½ - 3
2 ¼ - 2 ¾
Hardening time
minutes
9 ¼ - 9 ¾
8 - 8 ½
Time to completion
minutes
28 - 29
24 - 25
Resistance to stretch
high
high
Drape high
high
Memory (after 200 % elongation)
full
full
Maximum elongation when activated
%
1050
1400
Memory (after maximum elongation)
full
full
Sticks to itself when activated and wet
temporarily
temporarily
Sticks to itself when activated, after drying
temporarily
temporarily
Adhesion (velcro strip) using heat gun
no
no
Flexural modulus
MPa 530 505
Elastic modulus
MPa
310
275
Tensile strength
MPa
21.5
17.0
Strain at break
%
no break
15
Density g cm-³ 1.13 1.13
Hardness (shore D)
60
60
Surface feeling smooth
smooth
Color
skin
skin
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
TECHNICAL DATA SHEET
INFORMATION
www.orfit.com
© ORFIT INDUSTRIES N.V.
Belgium T +32 (0)3 326 20 26 America T 516-935-8500
Ref.: 80012 – ORFIT NS.docx VERSION 3
LAST UPDATE: 08/09/2016
The hardening time indicates the time period during which the material remains flexible, but no longer mouldable.
The time to completion indicates the length of time until the orthosis is finished and can be worn by the patient.
The memory indicates the ability of the material to regain its original shape after reheating.
The flexural modulus indicates the resistance of the material to a force causing it to bend.
The elastic modulus defines the ratio of the applied tensile stress to the change in shape of the material.
The tensile strength is the pulling force required to break the material.
The strain at break is the length increase of the material when stretched until failure.
The hardness indicates the resistance of the material to compression.
Fatigue indicates the minimum number of stress cycles the material sustains when bending over 90 degrees without failure.
The biocompatibility is studied according the guidelines of the International Organization for Standardization 10993 – Biological Evaluation of Medical Devices:
o Primary skin irritation study. o Delayed dermal contact sensitization study. o Cytotoxicity study.
Note:
Although the information in this publication is believed to be accurate and reliable, the data shown are for guidance only. Orfit Industries gives no guarantees about the results and assumes no liability in connection with them. The properties reported here are intended primarily to facilitate comparison among Orfit products. Standard testing methods often allow alternative measuring methods. Therefore, data from other sheet manufacturers may not be directly comparable. For a dditional information, please contact Orfit Industries.
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