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SV600 english FireWire 03/2006 DK

Information and Operating Instruction

Skin-Visiometer® SV 600 FireWire

CK electronic GmbH Mathias-Brüggen-Str. 91

50829 Köln/Germany Telephone: ++49-221-956499-0

Fax: ++49-221-956499-1 e-mail: [email protected] website: www.courage-khazaka.de

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Contents

PART I - INFORMATION .................................................................6

1. Information on the Skin .......................................................7

1.1 The Structure of the Skin.............................................................. 7

1.2 The Hydrolipidic Film of the Stratum Corneum.......................... 8

1.3 The Microrelief of the Skin ........................................................... 8

1.4 Influences on Skin Roughness .................................................... 9

1.4.1 Physiological Factors ...............................................................................9

1.4.2 Environmental Factors..............................................................................9

2. Skin Profilometry................................................................10

2.1 Fields of Application ................................................................... 10

2.2 Overview on the Most Important Measuring Methods ............. 10

2.3 Measuring Principle of the Skin-Visiometer® SV 600............... 10

2.4 Advantages of the Skin-Visiometer® SV 600 ............................ 11

2.5 Sebum and Desquamation Measurement with the Skin-Visiometer® SV 600 ........................................................................... 12

2.5.1 The Sebum Measurement with the Sebufix® F 16.................................12

2.5.2 Advantages of the Sebufix® F 16 ...........................................................12

2.5.3 Desquamation Measurement with the Corneofix® F 20 .......................12

PART II - OPERATING INSTRUCTIONS ..........................................14

1. Delivery Content .................................................................15

2. Set Up and Special Advice ................................................15

2.1 Computer ..................................................................................... 15

2.2 Installation of the Software ........................................................ 16

SV600 english FireWire 03/2006 DK 3

2.3 Installation of the Hardware ....................................................... 17

2.4 Operation conditions .................................................................. 18

2.5 First Operation............................................................................. 18

2.6 Symbols ....................................................................................... 19

2.7 Safety Advice............................................................................... 19

2.8 Proper Application ...................................................................... 19

2.9 Repair ........................................................................................... 19

2.10 Controls...................................................................................... 19

2.11 Notes for the Product Liability ................................................. 19

2.12 Disposal ..................................................................................... 20

3. The Silicone Replica...........................................................20

3.1 Recommendation for Skin Replica Production ........................ 20

3.2 The Kit for the Replica Production ............................................ 20

3.3 Preparation .................................................................................. 21

3.4 Procedure..................................................................................... 22

4. The Software.......................................................................25

4.1 Operation of the Software .......................................................... 25

4.2 Getting an Image into the Program ........................................... 25

4.3 A Typical Image ........................................................................... 26

4.4 The Shutter .................................................................................. 29

5. The Main Menu....................................................................30

5.1 Menu „File“ .................................................................................. 30

5.1.1 „Open“......................................................................................................30

5.1.2 „Save“ ......................................................................................................30

5.1.3 „Save as ...“ .............................................................................................30

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5.1.4 „Close all“ ................................................................................................30

5.1.5 „Print“.......................................................................................................30

5.1.6 „Print several images“ ............................................................................31

5.1.7 „Example“ ................................................................................................31

5.1.8 „Exit“ ........................................................................................................31

5.2 Menu „Person“ ............................................................................ 31

5.2.1 „Open image“ ..........................................................................................31

5.2.2 „Save to database“..................................................................................33

5.2.3 „Delete“ ....................................................................................................34

5.2.4 „Modify“ ...................................................................................................36

5.3 The Menu „Measurements“........................................................ 36

5.3.1 „Calculation area“ ...................................................................................36

5.3.2 „Sebum“ and “Desquamation” ..............................................................36 5.3.2.1 Operation of the Sebufix® F 16 ...........................................................36 5.3.2.2 Measurement with the Sebufix® F 16..................................................37 5.3.2.4 Operation with the Corneofix® F 20.....................................................38 5.3.2.5 Measurement with Corneofix® F 20 ....................................................38 5.3.2.6 Further Proceeding on the Results of Sebufix® and Cornoefix®..........40 5.3.2.7 Example of a Typical Study with Sebufix® F 16 and Cornoefix® F 20 .41

5.3.3 „Surface“ (Measurements on the skin replica).....................................41

5.3.4 „Volume“..................................................................................................42

5.3.5 „Roughness“ ...........................................................................................42

5.4 Menu „Multi Image Analysis“..................................................... 43

5.4.1 „Calculate“...............................................................................................44

5.4.2 „Show results“ ........................................................................................45

5.4.3 „Clear Results“........................................................................................45

5.4.4 Evaluation of the Results........................................................................46

5.4.5 Example of a Typical Roughness Study................................................46

5.5 Menu „Image Proccessing“........................................................ 46

5.5.1 „Automatic Filter Selection“...................................................................47

5.5.2 „Filter“ ......................................................................................................48


5.5.3 „Color“ .....................................................................................................49

5.6 The Menu „Configuration“ ......................................................... 50

5.6.1 „Language“..............................................................................................50

5.6.2 “Background”..........................................................................................50

5.6.3 “Calibration” ............................................................................................52

5.6.4 „Calculation Parameter“ .........................................................................54

5.6.5 „Registry“ ................................................................................................54

5.6.6 „New PIN“ ................................................................................................55

5.7 Menu „Information“..................................................................... 56

5.8 Menu „Window“........................................................................... 56

5.9 Menu „Help“................................................................................. 56

6. Maintenance of the Devices ..............................................56

7. Technical Data ....................................................................56

8. Classification ......................................................................57

9. Declaration of Conformity..................................................58

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PART I - INFORMATION


1. Information on the Skin Our skin is more than just a living coat, it is a real multi talent. The skin is responsible for many vital functions. It shields the organism from the environment and is in direct contact with it at the same time. The skin receives warmth and cold as well as the feeling of well-being and pain. Like a chemical plant it processes drugs and poisons and produces enzymes and hormones. It offers protection against bumps, pressure and friction. Its natural acidic bar-rier prevents germs from intruding. In a word, our skin performs extraordinary work around the clock. Therefore it deserves special attention, in particular if some of its functions are dis-turbed.

1.1 The Structure of the Skin Human skin consists of three layers. Each layer has particular tasks, but works in harmony with the next layer.

Geo, 1/1988

1. Epidermis 2. Dermal rete ridge 3. Hair bulb 4. Sebaceous gland 5. Dermal papillae 6. Artery 7. Vein 8. Lymphatic vessel 9. Nerve 10. Pacinian corpuscle 11. Meissner’s corpuscle 12. Pore of a sweat gland 13. Collagen fibers 14. Subcutaneous fatty tissue 15. Muscular membrane 16. Muscle

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• The Epidermis The Epidermis is the outer layer of our body and therefore in close contact with the envi-ronment. It is relatively thin and meshes with the next layer, the Dermis, by its indented profile. The epidermis itself consists of different layers. The Stratum germinativum steadily renews the skin and is responsible for the production of melanin (tanning). Cells continuously gen-erate in this layer dividing and multiplying themselves. These newly formed cells move to the outside where they form the Stratum corneum as horny disks. This process takes 4 weeks in healthy skin. Due to this process cells are transformed into keratin, become flatter and flatter and eventually die. They are then released from the surface singly or as small scales to give room for new cells.

• The Dermis The Dermis is responsible for the elastic properties of the skin. Collagen and elastic fibers stabilize the skin and prevent it from being torn. The sensory cells are also located in this layer. All sensations (pain, itching, temperature etc.) are transferred from the receptors via nerves to the brain as electric impulses. The high content of chondoitin and hyaluronic acid provides a liquid depot which nourishes the epidermal cells.

• The Subcutis

This is the bottom layer of the skin. It contains fat cells as well as nutrients, blood-vessels, sebaceous glands, sweat glands and arrector pili muscles for the hairs. It therefore serves as a depot and as protection against bumps. Normally the fat cells are the main component. Their volume, the thickness of the layer and the arrangement of the cells is constitutionally and hormonally regulated. The subcutaneous fat cells are very rare on the nose, the eyelids and the outer ear only.

1.2 The Hydrolipidic Film of the Stratum Corneum An important parameter of the skin is the hydrolipidic film, which consists of sebum excreted by the sebaceous glands and moisture components excreted with sweat. This emulsion pro-tects the skin from drying out, keeps it supple and due to the natural acid protection barrier it prevents the penetration of harmful external substances (e. g. germs). Any disorder of the hydrolipid film causes problems ranging from skin irritation to skin dis-eases. Even cleansing of the skin disturbs the balance of the hydrolipid film. In healthy skin this is not alarming as the sebaceous glands begin to work instantly. In sensitive skin the hy-drolipidic film can be disturbed permanently, thus decreasing the protection function of the skin. The composition of the hydrolipidic film varies and is dependent on different parameters. The sebaceous glands can be found everywhere on the skin surface. They produce 1-5 g of a complex mixture of lipids per day. Most important for the moisture balance of the skin is the horny layer (stratum corneum). The living layers laying beneath are almost constantly hydrated.

1.3 The Microrelief of the Skin The skin surface is intersected by primary and secondary lines like a topographical map with plateaus and valleys. The mircrorelief is a good indicator for the skin ageing process. The primary lines are characteristic for each individual person, age and body site. They are influenced by external factors, like temperature, humidity, cosmetics, food and drugs. Changes in the Microrelief are closely linked to the loss of the elastic fibers in the Dermis.


Young skin is characterized by a great number of fine lines holding the skin firm like a net. With increasing age, these fine lines are more or less „swept away“ and the primary lines deepen.

Skin structure of a 20 year old woman Skin structure of a 50 year old woman

1.4 Influences on Skin Roughness Many studies characterize the factors which influence skin elasticity. Please contact the sup-plier for detailed references.

1.4.1 Physiological Factors For the Epidermis, its protection coat and the roughness of the skin surface water content is most important. The more balanced the hydrolipidic film the smoother the skin surface. The measured body site influences the moisture content and thus also the roughness of the skin, especially the thickness of the stratum corneum and the number and activity of the sweat gland. Age has a very big influence on skin roughness. With increasing age the number of collagen and elastine fibers are reduced and elasticity decreases significantly. Premature ageing due to light plays an important role in this context. Skin diseases and internal diseases as well as healing of wounds and scars have influence on the roughness.

1.4.2 Environmental Factors The UV radiation of the sun has a very large influence on the profile of the skin surface. In particular the UV-A radiation penetrates the skin to the dermis and damages the elastine and collagen fibers. The result is premature ageing. Lifestyle , e.g. smoking, alcohol, drugs, food and sleep, also determines the structure of the skin. A young person with an unhealthy lifestyle could therefore have older skin characteris-tics than an old person with a healthy lifestyle. Pharmaceuticals and cosmetic products have an effect on skin roughness. All skin parameters are influenced by the environmental conditions. The higher the air hu-midity and the room temperature the higher the moisture level of the skin. Ideal measuring conditions are approx. 20° C and approx. 50 % air humidity. Therefore season and climate also influence the moisture measurement. Because of the low air humidity in winter the water content of the hydrolipidic film is low. Additional strain by often washing the skin, may lead

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to extreme dehydration of the skin. In summer transpiration is higher, but due to the increased air humidity, less water can evaporate from the skin and the stratum corneum is more hy-drated.

2. Skin Profilometry

2.1 Fields of Application As a result of the new requirements Europe of the 6th Amendment of the Directive for Cos-metic Products regarding efficacy testing and claim support of cosmetic products and raw materials skin roughness measurements have become indispensable. Effects of detergents, peelings and age of the skin can be proved. Skin roughness measurements also play a big role in the classification of skin conditions in dermatology.

2.2 Overview on the Most Important Measuring Methods For more than 40 years the cosmetic industry has been researching skin roughness measure-ments. The method derives from the metal industry where it is used to classify the quality of metal surfaces and varnish. Common for all measuring principles is the fact that roughness measurements cannot be performed directly on the skin but that a silicone replica, a negative of the skin, has to be made, as skin is a living organ and its dynamics (puls, muscle contrac-tion and respiration) would be registered as movements and would influence the measure-ments. Measuring principles based on this fact are called profilometry. Mechanical Stylus Instrument With this measuring principle a diamond needle reads the replica line by line. The received profiles for the lines are evaluated electronically and specific parameters can be calculated. Laser Profilometry Here laser beams analyze the structure of the replica line by line without touching it. The lines are evaluated digitally by a computer. Shadowing Method Another measurement illuminates the replica in a microscope by a light source in a precisely defined angle over the replica. The plateaus produce shadows which are measured. This method underlies various influences (e.g. the exact placement of the replica, influences of ambient light).

2.3 Measuring Principle of the Skin-Visiometer® SV 600 The measuring principle of the Skin-Visiometer® SV 600 is based on light transmission of a very thin, especially blue dyed silicone replica. Of the blue color the light absorption is known. The replica is put on a special frame and inserted in the special device where a light source sending out parallel light and a videosensor CCD-camera with 640 x 480 pixel on the other side. The spectrum of the light source gives a maximum absorption of the blue silicone mate-rial. The light penetrates the replica and is absorbed according to the thickness of the replica. The replica reproduces the skin as a negative, i. e. wrinkles are reproduced as mountains as the silicone is thicker in that place. The portion of the absorbed light is calculated by


Lambert & Beer’s law: φex = φin • e -kd

The visualization is done by an video digitalization unit. On the PC screen the heights and depth (z) of the picture are displayed in a corresponding classification in 256 gray values (0 = black, 256 = white) and they are calculated in microme-ters by the software. The Skin-Visiometer® SV 600 can calculate the depth of wrinkles from 20-300 μm. Compared with other methods Skin-Visiometer® SV 600 distinguishes itself by high ac-curacy combined with quick and easy handling. The visualization and the evaluation of the depth of each pixel in the image in done in seconds.It offers a variety of possibilities and became an indispensable tool for cosmetology and dermatology.

2.4 Advantages of the Skin-Visiometer® SV 600 • For the first time the Skin-Visiometer® SV 600 is equipped with a FireWire port. Thus

the device can be very easily connected to ther PC and a high resolution, quick life image in the program shows each replica directly in the program. There is no need to connect a control video monitor in addition.

• The digitalization unit and video slide unit are combined in one housing. The easy soft-ware makes quick analysis possible.

• With the measurement method of the Skin-Visiometer® SV 600 3D information on the whole image is immediately available, because the x-, the y- and also the z-coordinates (depth) are known. Other measurements have the 3D information only for the single lines they draw.

• This fact makes it possible to calculate not only the standard roughness parameters (laid down in DIN 4762-4768). With other measurement methods this is expensive and very time consuming.

• Additionally special skin surface parameters can be calculated within a second. • A three dimensional colored image e. g. for marketing purpose is also built up in a few

seconds. The presentation phase and the amplitude can be chosen. • Up to 180 lines can be arranged horizontally, vertically or in a circle and calculated in one

second. The possibility of arranging lines circularly avoids influences arising from the di-rection of the wrinkles.All averages of the measurement values can be stored in a dBase-file and thus are available for statistical use (e. g. Excel®).

• Mathematical filter function monitor not only the skin roughness but also the roughness of each line.

d = Way length through the mediumk = Absorption constant

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• A Multi Image Analysis makes working with the program very convenient. A number of images can be stored automatically in a database to be analyzed at a later stage. All meas-urement parameters can be calculated over several images at the same time and can be added in a printable report.

• A person database allows you to store all information about the measured persons with their images and results to be available at any time.

• A variety of filter function let the user improve the image easily. • The calibration of the Skin-Visiometer® SV 600 can be easily and quickly done anytime. • The very viscous silicone fills even smallest skin depths and reproduces them in detail. It is

suitable for all skin replica and completely harmless to human health. • Sebum- and desquamation analysis with the special foils Sebufix® F 16 and Corneofix® F

20 (see below). • The Skin-Visiometer® SV 600 can be combined directly with the Visioscan® VC 98 thus

allows also to perform the SELS (surface evaluation of the living skin) analysis. • Quick and friendly customer service.

2.5 Sebum and Desquamation Measurement with the Skin-Visiometer® SV 600 The Skin-Visiometer® SV 600 does not only enable you to analyze skin roughness but also the sebum content and the desquamation of the skin surface with help of the special foils Se-bufix® F 16 and Corneofix® F 20 and the supplied software.

2.5.1 The Sebum Measurement with the Sebufix® F 16 The Sebufix® F 16 analyzes the sebum content of the skin not only quantitatively (size and number) but also qualitatively (how fast and how constantly the sebum production takes place). The principle is based on a special milky foil in which micropores the sebum is visible as black spots. The foil can be evaluated qualitatively or by means of image analysis systems also quantita-tively. Requirement for an exact measurement of the production and the distribution of the sebum is a short measuring time in order to avoid occlusion effect and to allow the skin a normal respi-ration and transepidermal waterloss. Occlusion leads to a welling up of the stratum corneum and thus influences the measurements. In addition low, but constant pressure on the skin sur-face is important to achieve reproducible measurements.

2.5.2 Advantages of the Sebufix® F 16 1. The side of the Sebufix® F 16 which is in contact with the skin is absolutely glue-free,

thus the sebum can enter the micropores of the foil directly and unchanged. This leads to the short measuring time of 30 s. after which the foil is ready to be evaluated. The more oily the skin is the less time can be used.

2. The short measuring time prevents occlusion effects which might influence the measure-ment. Flexible studies of all stages after cleansing the skin are possible.

3. The supplied holder presses the sf lightly but constantly on the skin and leads to exact, reproducible measurements which do not influence the structure of the skin.

4. The special measuring foil measures sebum only, not moisture.

2.5.3 Desquamation Measurement with the Corneofix® F 20 As already described in the chapter „structure of the skin“, the keratin cells, become flatter and flatter and eventually die. They are then released from the surface singly or as small


scales to give room for new cells. Depending on the quality of the hydrolipidic film, espe-cially depending on the moisture content, the corneocytes leave the skin in different quantity and sizes. The drier the skin surface the more and bigger corneocytes leave the skin. The desquamation measurement indirectly measures the moisture content of the stratum cor-neum. The Corneofix® F 20 is a transparent, sticking foil which is slightly pressed on the skin sur-face. The corneocytes stick to the foil and will be available for an analysis of number and size. As the light is absorbed differently due to the different thicknesses of the corneocytes they will appear as dark pixels in the image. Looking at the gray level distribution in the histogram the size and number can be calculated. The program automatically cuts the image into 5 lay-ers. The disadvantage of this automatic cutting is that for some images the shutter does not recognize the background properly. In these cases the user can set the shutter manually by comparing the original and the segmented image with an accuracy of ± 0.1 %. Until now the measurement had been quiet time consuming and difficult. The light tarnsmis-sion method of the Skin-Visiometer® SV 600 makes those measurements quickly possible but it is important that the user understands very well the measuring principle behind the evalua-tion. Please also read the corresponding menus “Measurement” “Sebum” and “Desquamation”.

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PART II - OPERATING INSTRUCTIONS


1. Delivery Content • Skin-Visiometer® SV 600 for light transmission of a skin replica with light source, optics

and integrated CCD-camera with USB interface to be connected to a PC • Software VISIOMETER® SV 600 FW for Windows® for image and data processing and

calculation of measuring parameters. • USB connection cable and FireWire connection cable for the PC • Dongle to secure the program • Power cable (2.5 – 3 m) • Vacuum pump to mix the silicone components with manual mixer and pedal • Kit to produce 100 silicone replica:

special double sided stickers special slide frames 2 component silicone (2 x 50 ml) cover foils (one sided sticker) stirring bottles stirring rods

• Calibration slide • 200 ml compressed air to clean video slide unit A • 100 Corneofix® F 20 and 100 Sebufix® F 16 (special foils to evaluate sebum and desqua-

mation) • Operation manual for Skin-Visiometer® SV 600 USB Additional Accessories: • Personal computer where software is installed Please notice that the camera Visioscan® VC 98 can be connected to the Skin-Visiometer® SV 600 and than be used with the program Visioscan FW.

2. Set Up and Special Advice

2.1 Computer To operate the software VISIOMETER® 2000 FW you need a PC including a color monitor with the following equipment is necessary: • PC must be IBM-compatible. The operating system must be Windows® XP or 2000. • The PC must have minimum 2 USB ports. One is to connect the device and the other one is

for the dongle. In addition a FireWire port must be available.

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• Please notice that the software needs the special program DirectX8.1 (or higher). With Windows® XP this is automatically installed on your computer. For older operation sys-tems it may have to be installed (according to the operation system). It can be installed from the CK-software CD (right mouse click “open”). It is located in the directory:\Win9x-NT\Tools\DirectX or you can download it from the Microsoft® website.

• The color depth of your screen must be set to 24 or 32 Bit. • Any printer must be installed with the computer. • A mouse must be connected.

2.2 Installation of the Software For the installation of the software, the device should not yet be connected to the computer. For the Skin-Visiometer® SV 600 the following drivers have to be installed:

• CK-USB-driver • Dongle Driver • FireWire Driver

In addition the program Skin-Visiometer® SV 600 Fire Wire has to be installed. Please proceed as follows: 1. Put the CD-Rom into the drive. The installation program will start automatically. The CD recognizes automatically if the necessary driver has already been installed. If not, it offer the installation first. Install only the USB driver (remove the tick for the camera driver) camera). Click „Install Driver“. The driver will now be installed. Since the CK drivers are not licensed with Windows® , please ignore the message “a not authorized driver will be installed….” And confirm with “continue installation”. After that the PC has to be rebooted. In case the CK-USB-driver has already been installed to your computer, quit the above dialog with “cancel” to reach the main menu of the installation CD. 2. Insert the supplied CD again. Since the USB-driver has already been installed go with “Cancel” directly in the main menu. Install under “Miscellaneous” directly the drivers “Fire-Wire-driver” and “Dongle-driver”. 3. Now connect the device to the PC using the USB cable and the FireWire cable. When it is connected for the first time it will automatically be recognized. The ports are now ready to be used. In case the drivers are not found despite its automatic installation, you have to install it manu-ally.


Insert the CK-software in your CD drive and click “from CD-Rom” in the window. The driver is located on the CK-software CD in Drivers/CK_USB. Always confirm with “Continue”. The driver will then be installed. To install the FireWire-driver go in the CD’s main menu to “Miscellaneous” and “FireWire-driver”. 4. Now install the software for the device. Insert the CK Software CD again (and leave the first driver installation dialog by “Cancel”). Select the software for Skin Visiometer SV 600 FW under “Scientific”. A short instruction leads you step by step through the installation. Confirm each step and enter which directory you want the software to be installed. The program says when the installation is finished. Now you can start to operate the device with software. To operate the program you need a basic knowledge of Microsoft Windows® and a PC. You should know how to use the mouse and standard Windows® menus and commands. For in-formation on basic Windows® features, see your Microsoft Windows® documentation.

2.3 Installation of the Hardware • The interface of the Skin-Visiometer® SV 600 must be firmly connected to the USB port

with the supplied interface cable. The Dongle is simply attaced to the other USB port. • Also the FireWire copnnection cable is connected to device and PC • PC-screen, keyboard and mouse are connected to the according ports of the PC. • Connect the power cord to the plug of the back of the Skin-Visiometer® SV 600

(“POWER”) Please only use the supplied or a power cable applying to the IEC-norm and connect it to a three-pin plug. For security reasons do not use multi-sockets and extension leads.Connect all power cords of all equipment to the mains.

• The green light in front of the Skin-Visiometer® SV 600 (“POWER”) show that the device has power. The device will be automatically switched on when connected to the computer and the computer is turned on, too. When the computer is turned off, also the Skin-Visiometer® SV 600 turns off, the llight will turn yellow.

Power

light

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2.4 Operation conditions The device must be installed and operated according to the IEC-norm for electronic installa-tion.

2.5 First Operation The user, with appropriate qualification, may only take the instrument into use after testing its functionality at the operation location due to the instruction manual.

USB inter-face for the connection to the PC port

Power cabel

Dongle FireWire connection cable to the PC


2.6 Symbols

Please see operating instructions

Attention: Dangerous electrical voltage

Protective earth

(Protection class I device with earth connection)

2.7 Safety Advice The Skin-Visiometer® SV 600 may only be operated with components complying to the European Guidelines, or accessories from the supplier. The European Guidelines are: • 73/23/EWG Low-Voltage-Directive • 89/336/EWG EMC-Directive The device must not be opened, repaired or changed by unauthorized persons. Otherwise we do not guarantee the operation safety any longer. Also, the warranty will expire before stipu-lated time of 1 year. To work with the device, please see also the advice in the chapter „maintenance of the de-vice“.

2.8 Proper Application The Skin-Visiometer® SV 600 system is meant for the use on undamaged skin. Please do not let the light of the camera come into the eye directly.

2.9 Repair In case of obvious damages, also at plugs and cables, the device has to be repair prior to its next operation. The repair may only be executed by Courage+Khazaka electronic GmbH or an authorized person.

2.10 Controls The followings checks have to be done on this instrument latest every 12 months:

• Device and probe have to be checked visually on defects impairing the performance. • Safety relevant labels must be readable.

Whenever the instrument is not safe in using and operating anymore it must not be operated but has to be sent to the supplier for repair.

2.11 Notes for the Product Liability Courage + Khazaka electronic GmbH is only responsible for safety and reliability and func-tionality of the device, if

• the device has been changed or repaired only by Courage + Khazaka or other author-ized persons.

• the electronic installation applies to the regulation in chapter “operation conditions” • the device is used according to the instruction manual.

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2.12 Disposal For the final disposal, please send in the device to the manufacturer.

3. The Silicone Replica

3.1 Recommendation for Skin Replica Production • For all measurements of skin parameters it is important to keep constant ambient condi-

tions. Temperature and relative humidity should be constant. This is indispensable for comparison of long-term measurements. The optimum room conditions are 20 C° and 40 - 60% relative humidity.

• Do not measure under direct lamp light or direct sunlight. Heat radiation might cause measurement inaccuracies. In case of series tests, always measure at the same time of the day and with the same light conditions.

• The test person’s skin should be cleansed and no products should be applied. • Let your test persons rest for at least 10-20 min., to get their blood circulation at a normal

level after physical exercises. Emotional stress may also lead to increased transpiration. • Prepare the production of the silicone replica thoroughly. As the silicone is fast harden-

ing all movements have to be made easily and quickly. • Choose the skin area to be measured carefully. If possible measure on hairless skin as

hair might damage the replica when taking it off the skin or cause inaccuracies. Should you wish to measure on hairy skin areas, it is recommended to shave the respective area some time before the measurement. A representative measuring site is e. g. the inside of the fore-arm close to the elbow. Skin tension should be constant, therefore place the forearm and the stretched open hand on a plane surface at a 90° angle.

The transmission-measuring-method with a Skin-Visiometer® SV 600 requires an extreme exact skin replica to guarantee very precise and reproducible results for evaluation.

3.2 The Kit for the Replica Production For the production of the skin replica the following accessories are needed:

1

2

7

4

3

5

6


A double sided adhesive ring (1), fulfilling several functions. Due to its size it determines the measured skin area, its height determines the thickness of the replica. The opening helps to let the excess silicone flow out and thus prevents from too much pressure on the skin. Attention should be paid that the opening always pointing in the same direction to guarantee the same position and orientation of the replica. The gray foil on the back protects the adhesive side from dirt and dust. The cover foil made of clear, flexible plastic (2) has one adhesive side and serves the purpose of making the back of the replica flat. It replaces the former used glass cover, which turned out not to be suitable because it used to break during removal from the skin. The 2-component silicone (3) consists of (B) basis and (C) catalyst, both having the same color intensity. Normally they should be mixed in a ration of 1:1. Using more catalyst will shorten the hardening time. Room temperature also influences the hardening time. If it is higher than 20° C, the silicone material should be kept in a refrigerator to avoid it hardening too quickly. The silicone material is also used in dental laboratories, therefore it is absolutely harmless to human health, even though contact with the eyes or open skin areas should be avoided. The small plastic stirring cup (4) is needed to mix the silicone, the stirring stick (5) is used to remove the mixed silicone from the cup. Both accessories should be stored clean and dustfree and can only be used for one replica. With the paper slide frame (6) the replica can be inserted in the video slide unit. The mixing facility of the vacuum pump (7) consists of stainless metal stick, easy to clean and a cover which fits optimally on the stirring cup (4). The mixing facility is connected to the vacuum pump by a tube. The pump is operated by mechanical pedal.

3.3 Preparation Prepare the production of the silicone replica thoroughly. As the silicone is fast hardening all movements have to be made easily and quickly. First, select the skin area for the relief measurement. The skin must be cleansed and com-pletely free of product residues. If water is used for cleansing wait at least 5 minutes before taking the replica. Please try to find an area without hair as they will damage the replica when removing from the skin or lead to errors in measurement.

8 mm 350 μm

The inside of the forearm close to the elbow, for instance, is a rep-resentative skin area. The skin tension should be the same at each replica test. This can be achieved by the defined position of thearms: the elbow should be positioned at a 90° angle, the forearmand the open, stretched hand on a level place. Mark the skin areayou want to measure by putting the double sided adhesive ring (1) on the skin a go around it with a pencil.

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Prepare the vacuum pump (7) with the mixing fixture and a small stirring cup (4). Check whether the mixing fixture is tight fitting on the stirring cup (4) by producing a vac-uum for test purposes. Also check whether the stirring rod of the mixing fixture reaches the bottom of the small stirring cup; if not push it slightly. The mixing facility must always be clean and dustfree. Furthermore prepare a shell to place the mixing fixture, both small bottles with silicone com-ponents (3), tissues, the ring with the cover foil (1+2), a small plastic stirring rod (5) and a special slide frame with the test person's number or name to stick on the finished replica (6) and to insert into the video slide unit (A). Check whether the opening of the slide is clean and free of splits. Protect your and the test person’s clothing because the silicone is hard to re-move from fabric.

3.4 Procedure 4-5 drops of each of the blue-colored silicone components ratio 1:1 is dropped into the small stirring cup (4). Start with component B (basis) and add component C (catalyst). Always fol-low this order to make sure not to use one component twice. Take care that the lid with the stirring compound (7) is fastened on tightly and activate the vacuum pump with the foot-pedal.

For long term studies mark it with a waterproof pencil or with a chemical marker only visible with ultra-violet light. Characteristic skin areas are cross-points of veins or other remarkable spots to mark preferred skin places with a measur-ing tape.

Now prepare one double sided adhesive ring (1) and a cover foil (2) by removing them from their roll. Please touch the foil only at its flap and the ring only with two fingers at the side. Never touch the middle part of the foil. Put both parts with their edges on the table and let them „fall“ together, so that they stick exactly to one another.

Put them aside on the table with the non adhesive side onthe table and take the cover foil off the ring. Remove thecover foil of the upper-side before sticking the special ring onto the skin in order to proceed continuously with the fol-lowing steps.


During the pump procedure (approx. 15 to 20 seconds) the material has to be mixed quickly but carefully in order to avoid even minor air bubbles in spite of the negative pressure. Listen to the sound of the pump to make sure it is working. The vacuum pump with the mixture facility is ideal for all measuring system using silicone replica. Beware that 1-2 drops are sufficient to produce a skin replica. This is important for the quality of the replica. If silicone comes over the borders of the ring or the ring varies in thickness on different sides the measurement results are heavily influenced.

Applying the silicone causes almost no pressure on the skin , therefore the natural profile remains and can be measured. Other measurement methods apply the silicone material heavily on the skin and change the profile tremendously.

After finishing the stirring process, switch off the pump and remove the lid very slowly. Move the mix-ing facility out of the way but pay attention to the sili-cone which might still drop down from the mixingstick. Immediately afterwards take out a large drop of the mixed silicone using the small plastic stirring rod (5) by turning it in one direction, and put it on the inside-space of the plastic ring.

Now take the ring with two fingers at the sides and place it with the side of the outflow-aperture on the skin and allow it to fall flat on the skin. Press slightly with the flat part of the stirring rod (5) or another object (e.g. pencil) from the side in direction to the aperture of the ring, to make the silicone material spread over the whole inside of the sticker.

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Please clean the stirring equipment after finishing the replica: the hardened silicone can easily be removed by hand. Making replica is the hardest part of the skin roughness measurement. Therefore a trial of 5-10 replica should be performed before starting with a study. The reproducibility is only dependent on the quality of the replica. At best, check the replica immediately in the Skin-Visiometer® SV 600 for its quality and usefulness, to be able to remake it if necessary.

After approx. one to two minutes the silicone material is hardened, however please wait 3-5 minutes due to extension effects. During the hardening phase the test person’s arm must rest still and relaxed on the table. After that time pe-riod the ring can be removed very carefully and slowly from the skin to avoid stretching the sili-cone. Always touch the replica at the flap.

For evaluation, the ring with the silicone-replica must be located exactly onto the marked area of the special carrier. That means with the sticker-surface of the ring which has been in contact with the skin before; the relief side of the replica lies exposed (uncovered) on the hole of the spe-cial carrier. Before inserting the slide in the Skin-Visiometer® SV 600 remove fingerprints on the outside with a dry tissue.

Now the special-carrier with the replica can be inserted into the magazine of the Skin-Visiometer® SV 600: the profile side of the replica must show in direction CCD-camera, the side covered with the small cover foil in direction of the light source.

When the magazin of the Skin-Visiometer® SV 600 is opened again, the replica should come out automatically. Ifnot use a pair of tweezers to take it cautiously out.


4. The Software

4.1 Operation of the Software The program is operated by „pop-up“ menus, i.e. in the headline you can find the menu titles. se the mouse or the cursor-keys to switch between the different titles and their commands. Click the left mouse-key or the RETURN-key to call up a command. Basically the program operates like all other software for Windows® , e.g. clicking an edge to close a window, etc. You will first see an example image. You can choose another example image with the menu “Configuration” “Registry”. In the top line you see the main menu. All menu points are ex-plained in the following pages. In case the software will not open, please check all connection cables, the dongle and the power connection.

4.2 Getting an Image into the Program

When inserting a replica (or Sebufix® or Cornoefix®) in the Skin-Visiometer® SV 600, it apperas in the „Capture“-Window. With the „Get Image“-button it comes into the software for fur-ther procceeding. The “camera” flashes shortly and the image appears in the main window.

In case no life image is visible (window is blue), use a right mouseclick in the image and set the channel to “0”.

In case the the „Get Image“-button is not active, the con-nection between device and PC is interrupted. Check all connection, close the software and call it up again.

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Due to the selection, automatical filter are applied to the image. The iamge is now ready for measurements. Please read the chapter “Measurements”. Use the commands „Se-bufix/Corneofix“ only for images really taken with the special foils. You can always check the actual selection in the toolbar. To change the settings please read the chapter “auto-matic filter selection”.

4.3 A Typical Image Click on the small image in the above tool bar to delete already drawn lines and squares on the image. Explanation of the image tool bar: Tools

Last steps of image processing done on the image.

Show profile. Click this button and draw a line. The corresponding profile will be dis-played and you can walk over it with your cursor. In the result-window you can see the actual cursor position under X, Y and Z.

When you want to capture the present life image into the software,depending on ist quality you can use automatic filters on it.

The filters depend on the setting in the tool bar (selection A, B, C or Sebufix/Corneofix).

The setting applies as long as no other setting is selected.

If you walk over the image with the cursor, here you will see the posi-tion within the image. If you draw a line with the cursor, you will also see the line length in the measuring result field under the x, y and z-coordinates.


You will see the original curve (green) and a smoothened curve (rot). The smoothened curves shows the profile without the roughness inside the single wrinkles. By choosing A, B or A/B you can look at each curve singly or together. The control button below allows to set the smooth filter low and high. Switching between A and B shows the roughness in the R-values in the measurement window.

By clicking the right mouse key additional functions are to your disposal.

You can zoom the profile: clicking on „whole scale“ shows the profile within the whole gray level distribution (0-255). „Automatic scale“ zoomes the profile so the only the actual gray levels of the image are shown. „With“ and „without logarism“ you can switch between the profile in real values (mm) or gray levels.

Show histogram. This command displays the gray level distribution, where dark values correspond to wrinkles and bright values to plateaus of the skin micro relief. Click this button and draw any rectangle with the cursor to see the histogram. The highest and the lowest gray level as well as the number of pixels in the histogram peek are displayed separately. Also when walking with the cursor in the histogram the actual gray level and the number of pixels for each graylevel are shown. The pixels appear red in the image while walking in the histo-gram.

3D image. More details below.

See here the highest and the lowest gray level in a sepa-rate field

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Draw calculation area. Choose the size of the calculation area by clicking the arrows on the side. Using the same calculation area is useful to cut the borders of the image which might lead to errors in the calculation due to variation in light transmission. In addition, using the same calculation area helps to make results of different images comparable. (0 = the whole image).

+ Profile of the diagonal of the calculation area.

+ Histogram of the calculation area.

+ 3D of the calculation area.

Exit.

Calculation area

Number of the calculation area. (0 = the whole image). The larger the number the smaller the rectangle.

Mouse

Clicking on the small image in the toolbar clears the image.

Double click on the main image adjusts to the size of the window.

3 D

A 3 D image of the skin surface before and after a treatmentis an impressive tool.

First select an rectangle and select between two 3D modes: Real image

In this mode all pixels are drawn. The calculation of the image takes a little longer than the calculation of a quick view image. The program uses a empty rectangle called container to move the direction of the view.

Quick image

The program selects some pixels to draw the view. The calculation is very quick and you can see the drawing in real time.

Tools

You can choose the color of the view. The result is a degraded color.


This function applies a special palette on the image. With the “page up” and “page down” keys you can tune the color setting.

Restores the original color.

This function draws a skeleton of the view and shows pixels with gray levels smaller than 125. It represents the horizontal cut of the view. You can modify the position of the cut by right-clicking and moving the mouse. The key ‘H’ permits to hide or show this skeleton.

This button hides or shows the grade of the palette.

brings the image back to the center of the window.

This button opens the print window.

Click this button to draw the real 3D in another position.

Keys

Arrows ← ↑ → ↓ permit the different position of the image.

Keys ‘+’ / ‘-’ make a zoom .

Key ‘S’ changes between different presentation views.

Key ‘H’ hides or shows the skeleton.

Left-click makes a rotation of the view.

Right-Click modifies the horizontal cut.

4.4 The Shutter

The shutter for the light source inside the device is controlled by the USB part. Double click where you see the red arrow and you will have the port selection. Select here the port to which your device is connected to via USB. Double click with the mouse again, to hide the port selection.

Ex works there are presettings of the shutter especially suitable for skin replica, Sebufix® and Cornoefix® and the calibration slide.

For skin replica the presetting of 2 or 3 is very suitable. For Sebufix® select 2, for Cornoefix®

select 1-2 and for the calibration slide always select 3.

In case the image still does not appear satisfactory use the shutter control button to control it manually. Normally the setting should not be changed.

Shutter preselection

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5. The Main Menu

5.1 Menu „File“ This menu contains all commands to load and store single images.

5.1.1 „Open“ With this command saved images can be called up again. Clicking on this command a selec-tion mask for the images to be opened appears. Click on the image to be opened or confirm an image you have clicked on once by “Open”. The image will appear on your screen.

5.1.2 „Save“ With this command an actual image an its measuring values can be saved to be called up at a later time. Give a useful name to the image which allows you to easily find the image and confirm by pressing “Save” or “Return”. Save all important images to have them available for the Multi Image Analysis. Please read the corresponding chapter.

5.1.3 „Save as ...“ With this command an already saved and reloaded image can be saved under another name. Give a useful name to the image which allows you to easily find the image back and confirm by pressing “Save” or “Return”. Remarks: The images are stored as „Bitmaps“ (bmp). You can also open them with other software as: Imaging®, Paint®, ...

5.1.4 „Close all“ With this command all images opened on the screen can be closed at once. Close single image by the exit button at its tool bar.

5.1.5 „Print“ With this command the actually opened image can be printed out. You will be asked to select whether you only want to print the image or additionally its gray level histogram and the pro-file of a line. The histogram and the profile however must be opened on the screen to be se-lected. If not and you still want to print it, leave the print menu first, open them and then re-turn. You will see a printout preview. Confirm with “Print” or set up your printer “Set up” or leave the print window “Close”.


5.1.6 „Print several images“

The name of all images available for the printout list are in the field on the right. Pressing the key “add from file” you will see all file names. Pressing “add from screen” all names of al-ready opened files will appear a double click on a name or the key select the marked im-age and let its name appear in the left printout field. The key selects all displayed images for the printout list.

Clicking on little trash box will delete one (or more) marked images from the selection.

Click “Preview” and confirm the printout in the preview with “Print” or set up your printer “Set up” or leave the print window “Close”. On one page the maximum of 4 images can be printed. If more than 4 images are selected for the printout you can preview also the previous or the last pages.

For questions concerning the printer setup, please see your printer manual.

5.1.7 „Example“ When all images are closed, this command will call up again the example image. You can change this ex work set image to any other by the command “Registry” in the menu “Con-figuration”. Please read the corresponding chapter.

5.1.8 „Exit“ „Exit“quits the program with a security confirmation.

5.2 Menu „Person“ This menu contains a database which allows you to save information and images of the meas-ured persons. The saved data can be called back up, changed and deleted. Images can be searched for quickly by the name of a person an image code or the entry date of the image. A useful code should always be saved with the image (e.g. name of the treatment product or measured skin area).

5.2.1 „Open image“ You can search for an image by the name of the person where the image is stored, the entry date to the database or a code. If you want to open an image of a certain person, enter the name. As soon as the entry is found, the person will be shown and you can confirm it by “Yes”

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You can also browse through the person database by the arrows at the side of the window:

First person (in alphabetical order)

Last person (in alphabetical order)

Previous person (in alphabetical order)

Next person (in alphabetical order)

When the person is selected the corresponding data and images are displayed (example: of image of Ms. Mueller): Click on an image or use the arrows at the side to see the information of the image.

First image of the selected person

Last image of the selected person

Previous image of the selected person

Next image of the selected person

You will see the name of the actual image, the code. Remarks are shown if any have been entered before. “Search” will lead you again to a selection window where you can select images by person, date or code. “Open” opens the actual image, “Open all” opens all images of this person and “Cancel” leads you back to the main menu.

Field for the personal data

saved images of this person

Last current calculation area


If you want to search for images by a certain code or entry date, click the “Code/Date” button in the opening dialog and enter code or entry date. To be able to search for images by a code it is necessary to store always an useful code with each image (e.g. name of the treatment product or measured skin area). The entry date is stored automatically by the program. All images of the selected code or entry date will be shown and you can proceed in this win-dow as described above..

5.2.2 „Save to database“ You can save images in the database by calling up an already stored person or by adding a new person to the database. You can also browse through the person database by the arrows at the side of the window:





If you enter data of a person which are already stored in the database, this person will be dis-played and you can confirm it with “Yes” if this is where you want to save the image. If new data are entered you can click on “Save” to add this person as new to the database. File name Each file name can only exist one time in the database, therefore the program suggests an unique name. If you want to accept this suggestion double click on it. Otherwise enter another name in the field. Code

Enter here additional data of the person as: (address, phone).

Here you can see previ-ously stored images

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The code is very useful to mark image as a series belonging together even when the images are stored under different persons. Therefore it makes sense to enter a code when saving the image. The code can identify an image e.g. by a treatment product, the measured skin area or the type of image and make it thus possible to open at once all images of one series.

Entry date

The entry date is automatically stored when the image is saved. Images can be searched for by an entry date, if you e.g. want to look at all images of a certain measuring day.

“Search” will lead you again to a selection window where you can select images by person. “Save” saves the data and goes back to the main menu, whereas “Cancel” leads you back to the main menu without saving.

5.2.3 „Delete“ There are some functions in the SV 2000 USB program which are secured by the entering of a PIN, in order to prevent unauthorized modifying or deleting of data. When calling up “De-lete” you are asked to enter the PIN: Ex works the PIN is set to 98765. It is recommended to change it to an individual PIN in the menu “Configuration” “New PIN”. Enter your PIN and confirm. After that the window where you can delete images or persons from the database appears: You can search for the images to be deleted by the name of the person where the image is stored, the entry date to the database or a code. You can delete single images of a person/code/entry date or all images of a person/code/entry date or the complete entry of a person. If you want to delete images of a certain person, enter the name. As soon as the entry is found, the person will be shown and you can confirm it by “Yes” You can also browse through the person database by the arrows at the side of the window:






With “Yes” the person is confirmed and after that single or all images can be deleted from the database. Pressing “Delete” in this window will delete the whole person and all its images from the database. Having selected the person with “Yes” you will see the personal data mask: “Search” will lead you again to a selection window where you can select images to be de-leted by person, date or code. “Delete” deletes the actual image, “Delete all” deletes all im-ages of the selected person and “Cancel” leads you back to the main menu. If you want to search for images to be deleted by a certain code or entry date, click the “Code/Date” button and enter code or entry date. To be able to search for images by a code it is necessary to store always an useful code with each image (e.g. name of the treatment prod-uct or measured skin area). The entry date is stored automatically by the program. The program will show you the same selection window as above, only you will find all im-ages of a certain code or date. “Search” will lead you again to a selection window where you can select images to be de-leted by person, date or code. “Delete” deletes the actual image, “Delete all” deletes all im-ages of the selected code or date and “Cancel” leads you back to the main menu.

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5.2.4 „Modify“ First you are asked for your PIN (see also chapter “Delete”). After that you can enter a person of which you want to modify data. The person is displayed and you can confirm with “Yes”. The software will also display a message if the entered name cannot be found in the database. Modify the data and press update to take over the modifications. “Restore” will bring the data to its original state.

5.3 The Menu „Measurements“ In this menu all kind of measurements can be executed on the actual image.

5.3.1 „Calculation area“ In order to seperate borders of the image which might vary from the rest of the image due to variations in light, the user can choose a calculation area. Also this helps to make images more comparable. You have 3 options: Fixed uses one of 9 squares for the measurement. Select which of the 9 you want to be the

basis for your measurements in toolbar over the image . Variable uses the last rectangle drawn on the image (e.g. if a histogram or a 3D image has been made before). The function „Whole image“ takes the complete image as the basis for calculations. Please note that the results of the measurements depend to a high amount on the se-lected calculation area. For comparison measurements, always use the same calculation area. We recommend the calculation area 2.

5.3.2 „Sebum“ and “Desquamation” the Skin-Visiometer® SV 600 offers the possibity to evaluate the special foils Sebufix® F 16 and Cornoefix® F 20 additionally to the evaluation of skin replica. Please read the following chapters thoroughly. We recommend to store the foils in a cool place (refrigerator) so that they keep their adhesive power.

5.3.2.1 Operation of the Sebufix® F 16 To perform a measurement with the Sebufix® F 16 please take out one foil from the packag-ing. Important: Please make sure that your hands are washed and oil free before touching the strip. The foil reacts very sensitively with oil. Any oil on your hand will influence the meas-urement. Never touch the white side.


5.3.2.2 Measurement with the Sebufix® F 16 The Sebufix® F 16 measures the sebum content of the skin surface. Carefully put it on the opening of one of the slide frames. Now you can put it on the skin area to be measured. Try to use a light constant pressure and to hold the Sebufix® F 16 still during the measuring time (max. 30 s.). The more oily the skin the shorter you can choose the measurement time. Please hold the measurement time constant if you want to compare images. Always take care not to touch the white side of the foil which has been in contact with the skin. After the measurement is finished, insert the slide in the Skin-Visiometer® SV 600 (the white side in direction to the light source) and watch the life image in the “capture” window. A typical image with the Sebufix® F 16 looks like this:

Normally, to look at the Sebufix®

images, the shutter has to be set darker. Select the shutter presetting of 2 (also read the chapter “Shutter”). Get the image in the program with the setting „Sebufix“ in tool bar.

The white spots represent the activity of the sebum glands. To evaluate the s ebum spots in size and number. Use the com-mand “Sebum” in the menu “measure-ments”.

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The image is displayed segmented in b/w. The two contro buttons “minimum” and “maximum” size allow you to change the borders of the categeories in case an images is not segmented at all or not segmentated satisfactory. Compare the segmented image to the original image. If necessary (not all spots are recognized or artefacts are recognized as spots or the image is not segmented at all) use the „manual“ controller to fix the background of the image which should be deducted from the spots. Click “Set” to overtake the setting. The whole image with the values is saved as an image automati-cally. The image can be found in the same directory as SV 2000 program, under „Image“. The file starts with the current date and a code for the image. The segmented image alone can also be opened in the menu „File“, „Open“. We recommend to always save the Sebufix® image immediately after the measurement. Al-ready 48 h after the measurement to our experience only 50 % of the sebum spots can be measured (shrinking of the hydrolipidic film).

5.3.2.4 Operation with the Corneofix® F 20 Take a Corneofix® F 20 out of the packaging by pulling its lappet. Important: Please make sure that your hands are washed and oilfree before touching the strip. Fingerprints on the foil may influence the measurement. Never touch directly on the foil.

5.3.2.5 Measurement with Corneofix® F 20 Before taking the image please procceed as follows:

categories of the pixel size. Under that the % of this category is displayed and the sebum area in in μm, as well as the number of spots. Press on „Show image“ to see this individual cate-gories in color.

You can see the sebum evolution as well as the categories of pixel as a bar graph or colored spots in the image


Press the sticking part of the foil to the skin and press with your thumb constantly to the foil so that it sticks to the skin evenly. After 5 seconds take it slowly off the skin by holding the lappet. Stick the side which has been in contact with the skin to the slide frame opening and insert in in the Skin-Visiometer® SV 600 (with the white side in direction to the light source) and watch the life image in the “capture” window. A typical image with the Corneofix® F 20 looks like this: The image is displayed segmented.

Normally, to look at the Corneofix®

images, the shutter has to be set darker. Use the shutter presetting of 1 or 2 (please also read the chapter “Shutter”). Get the image in the program with the setting „Corneofix“ in tool bar.

The different gray spots represent the different size and thickness of the des-quamation flakes (corneocytes). To evaluate them use the command “Des-quamation” in the menu “measure-ments”.

The different thickness of the corneocytes is shown in 5 different colors and their portion at the complete area is monitored.

The 5 categories can be seen in colors or as a bar graph. The complete desquamation index is calculated.

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Compare the segmented image to the original image. Automatically the program is set to rec-ognize the background and to separate it from the flakes. Under some circumstances however, not all corneocytes are recognized or artefacts are recognized as corneocytes, use the „man-ual“ controller to fix the background of the image which should be deducted from the corneo-cytes. Click “Set” to overtake the setting. The whole image with the values is saved as an im-age automatically. The image can be found in the same directory as SV 2000 program, under „Image“. The file starts with the current date and a code for the image. The segmented image alone can also be opened in the menu „File“, „Open“.

5.3.2.6 Further Proceeding on the Results of Sebufix® and Cornoefix® The data of the sebum and desquamation measurement are also available for statistical calcu-lations (e. g. Excel®), immediately after leaving this dialogue by “Close” (if “save results” is clicked). You will find the database in the same directory as your SV 2000 USB program un-der „Dermatology“, „Database“ and then „SebCorn“. Important: To find back the results more easily it is strongly recommended to first save and name the original images taken with Sebufix® and Cornoefix® as the results in the database are linked to that name. Opening the database with a statisctical program will look like that: „Image“ shows the name of the image and „Date“ the date of evaluation. Sebufix® results can be found in the following rows: SEBAREA zshows the percentage of the complete area covered with sebum spots. SEBPART shows the corresponding value in mm. CORNAVER shows the total number of sebum spots. G0-G4 shows the percentage of the spots in each category compared to the total area. G0 is the category of very small spots (less than 101 pixel/spot), G1 is the category of spots of 101-300 pixel/spot, G2 is the category of spots of 301-500 pixel/spot, G3 the category of spots of 501-1000 pixel/spot and G4 the category of big spots (more than 1000 pixel/spot). the Corneofix® results can be found in the following rows: CORNFINE shows the complete surface covered with corneocytes in mm. CORNCOARSE shows the corresponding percentage. CORNIDX shows the desquamation index. G0-G4 shows the percentage of flakes in each thickness category compared to the total area. G0 is the categorie of the very thin, even layer of corneocytes, G4 is the category of the very thick flakes. The desquamation index is calculated from the distribution of the different cor-neocytes per category: (2A + Σ[ Tn x (n-1)])/6 A = total area covered with corneocytes in %, n = thickness of the corneocyte layer (histo-gram cut in 5 equal layers), Tn = Sum of the percentage of the single thickness layers. The higher the desquamation index the more scaly/dry was the corresponding skin site.


Attention: The dbase files can be easily opened with Excel®. In order not to destroy the form of the database do not save any changes when opened with Excel®. In order to proceed on the data, first use the “save as…” function to save them as an Excel® sheet.

5.3.2.7 Example of a Typical Study with Sebufix® F 16 and Cornoefix® F 20 Sebufix® F 16: You want to evaluate the sebum on the forehead of 50 volunteers. • Stick one Sebufix® to the slide (first mark the slides with Sebufix01 to Sebufix50) and use

it on the forehead of the first volunteer.. • Insert the slide Sebufix01 into the Skin-Visiometer® SV 600 (white side in direction to the

light source). • Check the shutter setting on the life image and note the setting to use it also for the 49

other images. Sie können das Bild im „Capture“-Fenster kontrollieren und mit der Blen-deneinstellung gut sichtbar machen. Notieren Sie die Blendeneinstellung. Holen Sie das Bild nun ins Bild-Fenster (Bild-holen Knopf). Achten Sie darauf, dass die Bilder mit der Einstellung „Bild hoDet the image with the setting „Get image – Sebufix“ in the toolbar. Other than replica or Corneofix® slides, Sebufix® images should directly be saved in-to the program as the sebum spots might change their size in the course of time. Save the ímage with the command „Save“ in the menu „File“. Use a name that allows you to easily find the image back (e.g. Sebufix01).

• Proceed in the same way with the slides 02 to 50. Use the same shutter setting if possible. • When all images are saved open them one after the other and use the command “Sebum”

form the menu “Measurements”. • Now the results are available for statistical use in the database Sebcorn. Corneofix®: You want to evaluate the desqamation on the forearm of 50 volunteers. • Stick one Corneofix® with the desqamation of the first volunteer to a slide (first mark the

slides with Cornefix01 to Corneofix50). Procced in the same way for the other 49 volun-teers. In case the taking of the corneocytes of the different volunteers goes on for quiet a long time, please store the Cornoefix® F 20 in a cool room (refrigerator) to avoid that they loose their adhesive power and the corneocytes might fall off.

• When finished, insert all slides into the Skin-Visiometer® SV 600 (white side in direction to the light source).

• Check the shutter setting on the life image and note the setting to use it also for the 49 other images. Get the image with the setting „Get image – Corneofix“ in the toolbar.

• Save all ímages with the command „Save“ in the menu „File“. Use a name that allows you to easily find the image back (e.g. Corneofix01). Use the same shutter setting if possible.

• When all images are saved open them one after the other and use the command “Desqua-mation” form the menu “Measurements”.

• Now the results are available for statistical use in the database Sebcorn.

5.3.3 „Surface“ (Measurements on the skin replica) This command calculates the size of the “wavy” surface in comparison to the streched (“ironed”) surface (x : 1). The smoother the area was before streching it, the closer the two values are together. The result is displayed in the result window “Surface” in % (e.g. 113 = the streched area is 13 % larger than the original surface).

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5.3.4 „Volume“ The command „Volume“ calculates the virtual amount of liquid needed in the calculation area to fill the image until the average height of all mountains. The smoother an area before filling up, the less virtual liquid is needed. The result is shown in the result window in the field “Volumn” in mm³. Please note that the results of “Surface” and “Volumn” depend to a high amount on the se-lected calculation area. For comparison measurements, always use the same calculation area.

5.3.5 „Roughness“ The results R1 – R5 The roughness parameters R1 – R5 derive originally from the metal industry and are leaned on to the directive DIN 4762-4768 as Ra-Rz. Choose if the lines should be arranged horizon-tally, vertically or circularly and how many lines should be drwn automatically (max. 180). The advantage of circularly arranged lines is that an influence from the direction of the wrin-kles is compensated. For further information click the values to receive a help menu. In the report of the Multi Image Analysis the average of the horizontal and vertical lines can be calculated as well. The results “Roughness” depend to a high amount on the size of the calculation area! Use the same calculation area all the time if you want to compare images. Maximum Roughness R2: R2 is the biggest roughness of the different segment roughnesses. In the DIN norm this parameter is known as Rm or Rmax.

original area

wavy area

z 1 z 2 z 3 z 4 z 5

R2


Average Roughness R3: The average roughness is the arithmetic average of the different segment roughnesses calculated from 5 succeeding measurement segments of the same length. In contrast to R1, R3 is not that much influenced by artifacts due to calculating the average. In the DIN norm this parameter is known as Rz. The quantitative context between the parameters is as follows: R1 ≥ R2 ≥ R3. Smoothness Depth R4: This parameter describes the area above the real profile and a line drawn above the highest mountain (reference profile). This area is devided by the average height of the profile, therefore R4 is distance. R4 is the average distance between real profile and reference profile. In the DIN norm this parameter is known as Rp. Arithmetic Average Roughness R5: The area surrounded by the profile and the average pro-file is calculated. The average profile is the profile on the average height between the real profile and the reference profile drawn on top of the heighest mountain (see above). The area is devided by the average height, thus R5 is a distance: the distance describing the standard deviation of the reference profile to R4. In the DIN norm this parameter is known as Ra. As those parameters derive from the metal industry and depend very much on the length of the selected lines, for skin also the other parameters as surface or volume should not be neglected.

5.4 Menu „Multi Image Analysis“ In this menu you have the possibility to perform measurements on already saved images and to print out your results in a report. All selected images and results are stored in the Multi Image database. The database can be opened by Microsoft Excel®. This feature is important

average profile

R5

area R4

average profile

real profile

reference pro-file

average height of the profile

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to save images and their results for good and to evaluate the results statistically. Please read the following chapter with attention!

5.4.1 „Calculate“

The name of all images available for the report are in the right field. Pressing the key “add from file” you will see all file names. Pressing “add from screen” all names of already opened files will appear a double click on a name or the key select the marked image and let its name appear in the left selection field. The key selects all displayed images for the list.

Clicking on little trash box will delete one (or more) marked images from the selection.

Click “Select measurements” and select the measurements which should be done on the im-ages.

After selecting the measurements and closing the window, press “add to report” to see the printable report. You are asked to set the measurement configuration to make all measurements comparable.

Choose the size of the calculation area with the arrows. A defined calculation area is needed to seperate borders of the image which might vary from the rest of the image due to variations in light and to make images more comparable. After the calculations, please select the results you want to see in the report.


Due to limitations by the page the report cannot show all parameters. Therefore a message appears, when the page of the report is full. To take other parameters in the report, first some have to be deleted from the selection to make room for others.

For the explanation of the parameters, please read the chapter “Measurements”. The preview of the printout looks like this: and can be printed.

5.4.2 „Show results“ This cammand leads you directly to the selection window for the rsults to be seen in the re-port. Precondition is, that you have selected images in the Multi Image datbase before. Please also read the previous chapter “Calculate”. Note: If you want to do the “Multi Image Analysis” over all images stroed under a per-son/code/entry date, first select the person/code/entry date and then open all image by clicking on “Open all”. In the “Multi Image Analysis” select “add from screen” to have all those images in the selection list.

5.4.3 „Clear Results“ With this command you can delete all results from the Multi Image Analysis database. After that all functions of this menu can be used on other image selections.

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5.4.4 Evaluation of the Results The data of the Multi Image Analysis database are also for statistical calculations (e. g. Excel®) to your disposal. You will find the database in the same directory as your SV 2000 USB program under „DB Report“, „Database“ and then „MIA“. Open the file e.g. with Excel®. NAME is the name of the image. LL shows the line length, H, V and C correspond to horizontal, vertical and circular lines, R1-5 corresponds to R-parameters, SURFACE and VOLUME for the parameters with the same name. The MIA-database is a temporarily database, i. e. as soon as the data are deleted in the Vi-someter-program, the database is available for new results. To save your data permanently, open the database with Excel® and save it with “Save as” with a useful name. Never save any changes in the dbase file as this will destroy the database.

5.4.5 Example of a Typical Roughness Study You want to do a study on 50 test persons. Therefore you made replicas of the skin on the forearm on 50 women aged 40-60 years old. Write numbers from 01 to 50 on the replicas and proceed as follows: • Put replica number 01 in the Skin-Visiometer® SV 600. • Check it on the video monitor and if it is ok, get it into the software. • Save the image with the command under PERSON to a certain person with the code of

your study. • Procceed in the same way for the replica 02 bis 50. Important is to always eneter the same

code. (For large studies over a longer time period we recommend the following procedure: After having made a replica, check it in the “capture”-window and store it dustfree in a slide magazine. When all replica are finished, store one after the other as described above. You can then be sure to have stored all images with the same calibration setting). • Make sure that no images are opened on the screen. • Call up all images of your study code (PERSON, „open by code“ and when all images of

the code are shown, select „open all“ • For the measurements call up the command MULTI IMAGE ANALYSIS „calculate“ and

choose all 50 images („add from screen“ „add all (double arrow)“). • Select the parameters you want to have calculated. • Select MULTI IMAGE ANALYSE „show results“ to see the report of the results. Also a

program like Microsoft Excel® is quiete suitable for a statistical evaluation. Call it up and open the MultiImage dbase-file. All data are available then (see above).

5.5 Menu „Image Proccessing“ In this menu, you will find functions to change the view of an image for different reasons. Attention: The following commands only serve for different view of the image on the screen. Results on filtered images vary from results of original images.


5.5.1 „Automatic Filter Selection“ This command sets filters to be applied before the life image is taken into the pro-gram.and do not influence the measuring results. The dialogue allows you to select functions which are automatically applied on an image de-pending on the mode is set in the toolbar. Thus images can be improved before they appear on the screen. Please be aware that once the image is taken with filters in the program it can only be saved this way and will be available for further evaluation (e.g. Multi Image Analysis). Please only compare images taken with the same filter. • To add a function to the macro, click on it. • To delete a function from the macro, mark it in the list and press “Del”. • To change the order of applied functions, mark a function in the list and keep it marked

while moving it to the desired position with the cursor. • Choose selection A, B or C to save your automatic filter setting. • Press “Close” to save your setting, press “Cancel” to return to the main menu without

saving changes. • You can call the preset selection from the toolbar. Explanation of the filters: Delete unsignificant gray levels This command finds the distribution of each gray level. Then it cuts at the left and right bor-der all gray levels which do not occur more often than 1 %. The function “cleans” the image from artefacts (e.g. dust). Background The light source in the Skin-Visiometer® SV 600 is ball-shaped to avoid that the replica is illuminated unevenly by parallel light. However it is important to compensate possible varia-tions in the light. The light setting is stored in the software (Please also read „Configuration“ „Background“). The stored value can be deducted from an image to correct it. The result is an image free of light variations.

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Plan function: This function deletes the image background from the images and draws deviations from the average value. The result is a smoother and stiller image.

Optimize color: This function changes the color palette of the image in order to improve it.

Smooth filter:

This function draws a smoother image without extreme mountains and valleys. For each pixel of the image the surrounding images are taken into account and are brought into an order. The value in the middle is taken as a new value for this pixel. Especially if the image has hard contrast this is a useful function.

All commands should only be used once each on each image. If they are applied more often on one image the result will vary a lot from the original image.

5.5.2 „Filter“ Here you can find filters to improve the image. Plan filters: These functions delete the image background from the images and draws devia-tions from the average value. The result is a smoother and stiller image.

Smooth filters: These functions draws a smoother image without extreme mountains and val-leys. For each pixel of the image the surrounding images are taken into account and are brought into an order. The value in the middle is taken as a new value for this pixel. Espe-cially if the image has hard contrast this is a useful function.

Relief: This commands filters the dark gray levels thus showing a more plastic image.

Cut histogram: This function processes on the histogram. It deletes the border pixels (b/w) which are not significant and spreads the rest over the maximum range (0;255)with a loga-rithm. The result is a clear image.

Set 2 thresholds at the borders of the histogram. The pixels in-between are spread over the maximum range of gray levels (0;255). The function can also set automatically thresholds and cut 1, 2, 3 or 4 % of the pixels.

If you want to set different thresholds (e. g. cut more than 4 %), click on the histogram. When appears the position of the thresholds can changed. In the field „% deleted“ you can check

your setting.

Make a segmented image (b/w): This function leads to an image with only two colors (black and white)


Manual: Enter the threshold for the segmentation. All values below the threshold are shown in black, all above in white.

Automatic: The threshold is set automatical due to the histogram.

If you click „process on result“ all selected filters are processed on the same image, one after the other.

5.5.3 „Color“ Negative: This command exchanges colors, so that a negative image is seen. Measurements however, should only be performed on the original image. Optimize color: This function changes the color in order to improve contrast. Focus on gray values: This function outlines some gray values in particular. „OK“ takes over this setting and „Cancel“ leaves the function without executing it.

Select here if you want to point out one single gray value or a group of gray values. Choose the color by clicking on the color field. Click on „Add“ and select the gray val-ues/group of gray values in the scale with the cursor.

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Change palette: A variety of color palettes exist to improve the image. If you click „process on result“ all selected filters are processed on the same image, one after the other.

5.6 The Menu „Configuration“

5.6.1 „Language“ Choose the language of the software: English, French or German. All texts and buttons will appear in this language.

5.6.2 “Background” The light source in the Skin-Visiometer® SV 600 is ball-shaped to avoid that the replica is illuminated unevenly by parallel light. However it is important to compensate possible varia-tions in the light. With the command „background“ the light setting is stored and dokumented in the software. This value can be deducted from an image in order to correct it. The result is an image free of light variations. Normally due to the high stability of the light source, the command „background“ should not need to be executed any further time. However, to be sure that the saved background is still set to the light source after transportation of the device, the com-mand should be executed once before the first use of the instrumentation. After that it is only needed in the following cases: • before a calibration When the Skin-Visiometer® SV 600 has been opened 1. and the light source has been changed 2. and the objective of the camera is very dirty or 3. the objective or the camera have been changed In these cases execute the command „background“ followed by the calibration.

Choose a prede-fined palette here and press „appli-cate“ and „OK“ to use it for the image.

Here you can create your own palette. Click on the original color/ final color and see a color selection to choose from. Press „appli-cate“ and „OK“ to use it for the image.


When the command is called up and you are asked to enter your PIN: Ex works the PIN is set to 98765. It is recommended to change it to an individual PIN in the menu “Configuration” “New PIN”. Enter your PIN and confirm. After that you are asked to enter an empty slide and. After doing so and confirming, the de-vice takes several background settings and stores the values. The shutter moves from 0 (Dark) slowly inot the bright range (around 250). Please also see the histogram of the gray value dis-tribution (chapter „Histogram“). The gray values must sit in the very bright, right area of the histogram (the maximum value should be very close to 200). If the gray value distribution is not optimal repeat the command. If the result is still not optimal contact the manufacturer. When a profile is drawn on the background image, you will see the correction curve which is automatically applied to an image when the automatic filter „background“ is chosen.

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5.6.3 “Calibration” Now proceed with the calibration Select the shutter presetting of 3. Here you can calibrate the system in x, y and z direction. With „activate“ the calibration is called up and you are asked to enter your PIN: Ex works the PIN is set to 98765. It is recommended to change it to an individual PIN in the menu “Configuration” “New PIN”. Enter your PIN and confirm. When the command „Calibration“ is called up, the calibration slide must be inserted in the Skin-Visiometer® SV 600 and this action must be confirmed. Always insert the slide with the white side of the frame facing the light source. If a videomonitor is connected to the system the image might appear very dark. This is nor-mal. The Skin-Visiometer® SV 600 now takes 10 different shutter configurations and auto-matically chooses the best, thus maximizes the quality of the image. This procedure takes ap After that, an instruction to mark the vertical borders of one circle will appear on the screen. Choose the borders of the middle circle (4 mm diameter). To mark the left border, place the cursor in the image and you will see a white line. Please hold the left mouse key until you have placed the line exactly on the border of the circle. When releasing the mouse key the line will turn green. Repeat this procedure for theright border. Confirm with „OK“ if the lines are sitting exactly on the borders and you accept the calibration in x-direction. Otherwise click „NO“ and repeat the marking.Then you are asked to proceed in the same way for the remain-ing horizontal border lines. Confirm with „OK“ if the lines are sitting exactly on the borders and you accept the calibartion in y-direction. Otherwise click „NO“ and repeat the marking.

The Skin-Visiometer® SV 600 is sup-plied with calibration replica with three circles (6,4 and 2 mm diameter) and three steps of 1 mm different height to each other. This replica is needed for the xy calibration as well as for the calibration of the depth (z).

Make sure that this slide is always clean and dustfree.


An instruction to select two rectangles appears. Choose two neighbored areas of different height on the calibration image with even gray color (one on the 4 mm and one on the 6 mm diameter circle). Draw a rectangle as big as possible with your mouse over the first area. Take care to choose a evenly colored part and do not include areas of neighbored steps. Confirm with „OK“ if the rectangles are exactly on the 4 and on the 6 mm step and you want to accept the calibartion in the z-direction. Otherwise click „NO“ and repeat the marking. After that a window to enter the values appears: Enter for x and y the diameter of the circle. Please enter „4“ as the diameter of the middle circle is 4 mm. For z enter the difference in height between the two steps in μm. Between each step the height difference is 100 μm (0.1 mm), therefore please enter 100 and confirm the calibration with „OK“

The entered values will be the basis for the calculation of gray levels in length and depth.

To check the x and y-values: Leave the calibration slide in the device and do not call up any other command. Select a line from one border of the middle circle to the border which is facing it. The line length (see result-window) must be exactly 4 mm (length shows 4.00). If you want to check the z-calibration, you can proceed as follows: Select a line over the steps where you had chosen the rectangles. When you walk over the profile, you will see the difference in height. It should be 0.1 mm (± 5). Naturally the steps are not 100 % even (due to the mold, the calibration replica was made of). If you are in the profile-window you can switch between μm and gray values by using the right mouse key (“with” and “without logarism”). For the calibration check use the μm display.

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Attention: Calibration has a strong influence on the measuring values, therefore please always calibrate thoroughly. Never calibrate in the middle of a study. Especially when performing the calibration turn the Skin-Visiometer® SV 600 on 30 minutes prior to calibration in order to achieve the optimal temperature of the device. Once the calibration is done, you do not have to repeat it as long as the Skin-Visiometer® SV 600 system remains the same. You should execute the calibartion before a bigger study and when you are starting to work with a new set of silicone to adjust the system exactly to the blue-value of this set.

5.6.4 „Calculation Parameter“ Here you can see certain basic settings of the program: „Shutter“ shows the shutter value of the last calibration (skin) and the command „back-ground“ (back), do not change them manually. With „Sebum“ and „Corneo“ you can save the own shutter settings which have proven suit-able to look at images taken with Sebufix® and Cornoefix®. Try yourself in the program which shutter setting makes Sebufix® and Corneofix® best visible.

5.6.5 „Registry“ There are some functions in the SV Fire Wire program which are secured by the entering of a PIN, in order to prevent unauthorized modifying or deleting of data. When calling up “Regis-try” you are asked to enter the PIN:

Serial port

Resolution

Set here the number of lines used for the roughness calculation R1-R5


Ex works the PIN is set to 98765. It is recommended to change it to an individual PIN in the menu “Configuration” “New PIN”. Enter your PIN and confirm. After that the registry window appears: Set all directories so that data and images can be found easily. With „Browse“ the setting can be changed. „OK“ takes over the setting whereas „Cancel“ leaves the window without changes in the setting. The database Multi Image Analysis is normally in the same directory as the SV 2000 FW pro-gram (either in the directory suggested during the installation or in the directory chosen by you).

5.6.6 „New PIN“ There are some functions in the SV 600 FW program which are secured by the entering of a PIN, in order to prevent unauthorized modifying or deleting of data. Ex works the PIN is set to 98765. It is however, recommended to change it to an individual PIN in the menu “Con-figuration” “New PIN”. Enter the old PIN and 2 x the newly chosen PIN and press „Valid“.

In this directory all images saved in the menu „File“ can be found.

In this directory all images and data of the person database can be found.

In this directory the images of the data-base Multi Image Analysis can be found

In this directory the color palettes can be found.

From this directory the example image from the menu „File“ and the beginning of the program is load.

Path where the background image is stored. Exe-cuting the background command, overwrites the image with the actual light setting. DO NOT DELETE!!!!

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5.7 Menu „Information“ This menu shows you with which software and hardware version you are working. Please always refer to these data when you have a request.

5.8 Menu „Window“ You are familiar to this menu from other programs based on Windows® . You can choose here the display form of your measuring fields or toolbars, zoom or miniaturize them, etc.

5.9 Menu „Help“ To call up the help texts you can either use F1 or this menu. In some parts of the function a mouse click will call up the help function as well (e.g. result window).

6. Maintenance of the Devices Clean the device, the cables and the PC with its accessories with a dry, soft tissue. If the de-vices are very dirty use an alcohol soaked tissue. Do not rub. Take care that no liquid enters the devices. Never open the device. Clean the light transmission unit with compressed air (especially before calibartion). Never clean or bring the device in contact with solvents.

7. Technical Data Device Power Supply 100-240 V, 50-60 Hz, 0.3 A Dimensions: 23 x 26 x 7 cm Weight: 4.5 kg Light Source: 5 cm Ø ball with 2.5 cm opening Ø, varnished in white with 20

white LEDs evenly distributed on the ball Measuring Principle light transmission/absorption Measuring Area: 7500 x 5000 μm ± 21 μm (360 x 274 pixels) Resolution: 640 x 480 x 8/10 Bit on the PC screen Video Output: 1 Vss Video an 75 Ω, b/w Control Output: max. 55 V, 50 mA DC, potentialfree, 3.5 mm monoplug (+ inside) Operation Conditions: T: 10-40° C

r.H.: 30-70 % RH optimal conditions: 20° C and 50 % RH Strorage Conditions: T: 0-70° C r.H.: 0-80 % RH Interface: USB and FireWire


Accessories Vaccuum Pump: Power Supply: 230 V AC (115 V, switchable) 13 VA, 2 x 1.6 A slow Dimensions: 20 x 25 x 15,5 cm Weight: 2.75 kg Pressure: 550-650 mbar Operation Conditions: T: 20-50° C

r.H.: 30-70 % RH optimal conditions: 20° C and 50 % RH Strorage Conditions: T: 0-70° C r.H.: 0-80 % RH

8. Classification Operation manner: Protection degree: Protection class: Not design for:

permanent operation IP 00 (against entering of liquids) 2 Operation in explosive environment

Technical changes may be effected without previous notice.

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9. Declaration of Conformity

EG – KONFORMITÄTSERKLÄRUNGEC - DECLARATION OF CONFORMITYDÉCLARATION CE DE CONFORMITÉ

Name des Herstellers: Courage + Khazaka electronic GmbH Manufacturer’s name Nom du fabricant

Adresse des Herstellers: Mathias-Brüggen-Straße 91 Manufacturer’s address 50829 Köln, Germany Adresse du fabricant Tel.: ++ 49 221 - 956499 - 0 Fax: ++ 49 221 - 956499 - 1

Wir erklären hiermit, dass das Produkt: We declare the conformity of our product Nous déclarons la conformité de notre produit

SKIN-VISIOMETER® SV 600 den einschlägigen Bestimmungen der nachstehenden Richtlinien entspricht: The products herewith comply with following directives à la directive ci-dessous

73/23/EWG Elektrische Betriebsmittel (Niederspannungsrichtlinie)

Low-voltage-directive geändert durch / ammended by

93/68/EWG

89/336/EWG EMV-Richtlinie EMC-directive

geändert durch / ammended by 91/263/EWG, 92/31/EWG, 93/68/EWG

Köln, 22.04.2002 Cologne

Geschäftsführer Technik Sicherheitsbeauftragter Senior Manager / Technical Division Safety officer for medical devices Directeur / Division Technique Responsable Sécurite (des dispositifs médicaux) Dipl.-Ing. Wilfried Courage Dipl.-Ing.(FH) Stefan Richter

information and operating instruction skin-visiometer sv ...€¦ · our skin is more than just a...

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