Orfit 24-5762-1 User Manual

Page 1
TECHNICAL DATA SHEET
ORFILIGHT® 1.6 mm (1/16”)
Thickness
mm (inches)
1.6 (1/16)
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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
1 ¾ - 2 ¼
Time to completion
minutes
10 - 11
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
1800
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
high stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 260
Elastic modulus
MPa
170
Tensile strength
MPa
8.0
Strain at break % 45
Density g cm-³ 0.85
Hardness (shore D)
47
Surface feeling smooth
Color
skin
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 2
TECHNICAL DATA SHEET
ORFILIGHT® 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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
2 ¾ - 3 ¼
Time to completion
minutes
11 - 12
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
2500
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
high stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 190
Elastic modulus
MPa
165
Tensile strength
MPa
8.0
Strain at break % 60
Density g cm-³ 0.80
Hardness (shore D)
47
Surface feeling smooth
Color
skin
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 3
TECHNICAL DATA SHEET
ORFILIGHT® 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
3 - 4
3 - 4
Transparent when activated
no
no
Working time
minutes
2 - 2 ½
1 ¾ - 2 ¼
Hardening time
minutes
4 ¾ - 5 ¼
3 ¾ - 4 ¼
Time to completion
minutes
20 - 21
15 - 16
Resistance to stretch
moderate
moderate
Drape high
high
Memory (after 200 % elongation)
high
high
Maximum elongation when activated
%
2300
2200
Memory (after maximum elongation)
high
high
Sticks to itself when activated and wet
yes
yes
Sticks to itself when activated, after drying
reliable under
high stress
reliable under
high stress
Adhesion (velcro strip) using heat gun
yes
yes
Flexural modulus
MPa 285 285
Elastic modulus
MPa
145
125
Tensile strength
MPa
10.0
8.0
Strain at break % 140
20
Density g cm-³ 0.80 0.80
Hardness (shore D)
47
47
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
Page 4
TECHNICAL DATA SHEET
ORFILIGHT® BLACK NS 1.6 mm (1/16”)
Thickness
mm (inches)
1.6 (1/16)
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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
1 ¾ - 2 ¼
Time to completion
minutes
10 - 11
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
1800
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 260
Elastic modulus
MPa
170
Tensile strength
MPa
8.0
Strain at break % 45
Density g cm-³ 0.85
Hardness (shore D)
47
Surface feeling smooth
Color
black
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 5
TECHNICAL DATA SHEET
ORFILIGHT® BLACK NS 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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
2 ¾ - 3 ¼
Time to completion
minutes
11 - 12
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
2500
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 190
Elastic modulus
MPa
165
Tensile strength
MPa
8.0
Strain at break % 60
Density g cm-³ 0.80
Hardness (shore D)
47
Surface feeling smooth
Color
black
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 6
TECHNICAL DATA SHEET
ORFILIGHT® BLACK NS 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
3 - 4
3 - 4
Transparent when activated
no
no
Working time
minutes
2 - 2 ½
1 ¾ - 2 ¼
Hardening time
minutes
4 ¾ - 5 ¼
3 ¾ - 4 ¼
Time to completion
minutes
20 - 21
15 - 16
Resistance to stretch
moderate
moderate
Drape high
high
Memory (after 200 % elongation)
high
high
Maximum elongation when activated
%
2300
2200
Memory (after maximum elongation)
high
high
Sticks to itself when activated and wet
yes
yes
Sticks to itself when activated, after drying
reliable under
low stress
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
yes
Flexural modulus
MPa 285 285
Elastic modulus
MPa
145
125
Tensile strength
MPa
10.0
8.0
Strain at break % 140
20
Density g cm-³ 0.80 0.80
Hardness (shore D)
47
47
Surface feeling smooth
smooth
Color
black
black
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 7
TECHNICAL DATA SHEET
ORFILIGHT® ATOMIC BLUE NS 1.6 mm (1/16”)
Thickness
mm (inches)
1.6 (1/16)
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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
1 ¾ - 2 ¼
Time to completion
minutes
10 - 11
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
1800
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 260
Elastic modulus
MPa
170
Tensile strength
MPa
8.0
Strain at break % 45
Density g cm-³ 0.85
Hardness (shore D)
47
Surface feeling smooth
Color
black
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 8
TECHNICAL DATA SHEET
ORFILIGHT® ATOMIC BLUE NS 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
no
Working time
minutes
1 - 1 ½
Hardening time
minutes
2 ¾ - 3 ¼
Time to completion
minutes
11 - 12
Resistance to stretch
moderate
Drape high
Memory (after 200 % elongation)
high
Maximum elongation when activated
%
2500
Memory (after maximum elongation)
high
Sticks to itself when activated and wet
yes
Sticks to itself when activated, after drying
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
Flexural modulus
MPa 190
Elastic modulus
MPa
165
Tensile strength
MPa
8.0
Strain at break % 60
Density g cm-³ 0.80
Hardness (shore D)
47
Surface feeling smooth
Color
atomic blue
Odor
none
Fatigue
cycles
> 10000
Biocompatible yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 9
TECHNICAL DATA SHEET
ORFILIGHT® ATOMIC BLUE NS 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
3 - 4
3 - 4
Transparent when activated
no
no
Working time
minutes
2 - 2 ½
1 ¾ - 2 ¼
Hardening time
minutes
4 ¾ - 5 ¼
3 ¾ - 4 ¼
Time to completion
minutes
20 - 21
15 - 16
Resistance to stretch
moderate
moderate
Drape high
high
Memory (after 200 % elongation)
high
high
Maximum elongation when activated
%
2300
2200
Memory (after maximum elongation)
high
high
Sticks to itself when activated and wet
yes
yes
Sticks to itself when activated, after drying
reliable under
low stress
reliable under
low stress
Adhesion (velcro strip) using heat gun
yes
yes
Flexural modulus
MPa 285 285
Elastic modulus
MPa
145
125
Tensile strength
MPa
10.0
8.0
Strain at break % 140
20
Density g cm-³ 0.80 0.80
Hardness (shore D)
47
47
Surface feeling smooth
smooth
Color atomic blue
atomic blue
Odor
none
none
Fatigue
cycles
> 10000
> 10000
Biocompatible yes
yes
Thermoforming conditions
Mechanical properties at 21°C
General properties
Page 10
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.: 80004 – ORFILIGHT.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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