HEINE DELTA 20 and DELTA 20 Plus Documentation System Instruction Manual

Contents Introduction ...3 Quick Guide to Dermatoscopy with a digital camera ... 4 1. Basics of the HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscopy System ... 4 1.1 The components ... 4 1.2 Technical requirements in the exam room ... 5 1.2.1 First steps ... 5 1.2.2 Important settings for the camera ... 5 1.2.3 Ideal conditions for photography in the exam room ... 6 1.2.4 The ideal equipment ... 6 1.3 Pre-selected camera settings ... 6 1.3.1 Full-body photos ... 7 1.3.2 Dermatoscopic Photos ... 7 1.4 Colour correction ... 8 1.5 Focusing ...9 2. Documentation of the skin surface ... 9 2.1 The suspect nevi should be identified and marked by the dermatologist ... 9 2.2 Torso documentation ... 9 2.3 Full-body documentation ... 10 2.4 Image management without special software ... 13 2.4.1 Identification of files by name ... 13 2.5 General software for photo documentation ... 14 3. Work-flow in documentation ... 15 4. Literature ... 15 5. Appendices ... 16,17 Appendix 1: Full-body map ... 16 Appendix 2: Work-flow chart for photo-documentation ... 17

2

Introduction The success rate in the diagnosis of pigmented skin lesions is about 65 % for less-experienced practitioners, or about 80 % for dermatologists with some experience, rising to 90 % for experienced specialists, a result which compares well with computer-aided diagnosis. The inevitable remaining margin of error, which often leads to a decision to excise when not completely sure, needs to be reduced to a minimum. The photo-documentation of pigmented skin structures gives the dermatologist a valuable basic method of continuously improving his accuracy of diagnosis. Only a well-documented, dermatological image of the nevus allows the examiner to compare his diagnosis with the histological result. Also, only a series of comparative images from repeated exams over time allow an early diagnosis of a developing malignant melanoma. Digital photography is the method of choice for optimum image documentation in Dermatology. The main advantages of the HEINE DELTA® 20 / DELTA® 20 Plus Documentation System are: • Instant availability of very high quality images, therefore better information for doctor and patient. • More flexibility of procedures and work-flow in the exam room. • The camera is equally well-suited for both full-body and for dermatoscopic photography. To begin with image documentation in a dermatology practice, you need some experience in the differential diagnosis of pigmented lesions as well as some basic knowledge of photography. It is important that a systematic work-flow pattern is established in your practice in order to assure the best-possible image quality, image management and reliable retrieval of the nevus image in the case of follow-up exams. The introduction of a new, special software must also be accompanied from the beginning by the establishment of a new work-flow in the routine running of the practice.This manual has been compiled with the intention of assisting you in taking this first step to get the best out of the HEINE DELTA® 20 / DELTA® 20 Plus Documentation System.

3

Quick Guide to Dermatoscopy with a digital camera • Fix the photo-adaptor on the lens mount of the camera. • Switch the camera on. • Choose the correct settings on the camera (see page 7). • Adjust the DELTA 20 / DELTA 20 Plus Dermatoscope eyepiece to the ‘camera’ position. • Connect the photo-adaptor to the DELTA 20 / DELTA 20 Plus and hold the camera in your left hand (for righthanded users). • Switch on the handle of the dermatoscope. • Moisten the lesion with an appropriate immersion liquid. • Place the contact plate gently on the lesion. • Take the photo. Read the instructions for the HEINE DELTA® 20 / DELTA® 20 Plus carefully and take the time to read the following instructions.

1. Basics of the HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscopy System 1.1 The components The HEINE DELTA® 20 / DELTA® 20 Plus Dermatoskopy System consists of the following components: • HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscope for fitting to a HEINE handle as power source. • Large polarisation contact plates (23 mm) with and without scale, for the DELTA 20 Plus. • Large immersion contact plates (23 mm) with and without scale, for the DELTA 20 / DELTA 20 Plus. • Small contact plate (8 mm). • HEINE adaptor cord 1.3 m. • HEINE battery or rechargeable handle. • HEINE photo adaptor. • Digital SLR camera (contact HEINE for recommended camera models or visit www.heine.com). The HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscopy System allows you to carry out visual exams, whole-body photos, dermatoscopic photos and digital documentation specifically designed to meet the needs of the dermatologist - all this with just one instrument system. The HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscope features wide angle optics to give an extended field of view with clear, crisp focus edge to edge. Compared with conventional scopes, the light from the 6 white LEDs is much brighter. You can use a 2.5 V battery or a 3.5V rechargeable handle as a power source. The contact plates are autoclavable.The large contact plate (23 mm) is used for normal exams, the small contact plate (8 mm) for areas of the body which are difficult to reach. The adaptor cord (Fig. 1) connects the DELTA 20 / DELTA 20 Plus to the handle. This simplifies singlehanded digital photography by giving you more freedom of movement. The HEINE BETA handles (Fig.1 and 2) are available for 2.5 V battery or 3.5 V rechargeable use. They can also be used to power a complete range of other HEINE diagnostic instruments. The HEINE photo adaptor (Fig.1 and 2) connects the dermatoscope firmly to the digital camera. It allows the dermatoscope head to rotate relative to the camera. The position of the focusing ring is not affected by this, so that you always get clearly-focused images. The photo adaptor can be instantly fitted or removed with one hand, making it ideal for everyday use in dermatology.

4

Fig. 1 Adaptor cord for one-handedoperation

Fig. 2 Dermatoscope attached to camera by photo adaptor

The instructions provided with the DELTA 20 / DELTA 20 Plus and photo adaptor give useful information on using and cleaning the instrument.

1.2 Technical requirements in the exam room 1.2.1 First Steps We recommend that all members of the practice team agree on the procedure for systematic image and data management. This will ensure that the system works effectively in the daily routine. It is important that the whole team understands what is to be done and how. Get to know the camera and keep the instruction leaflet handy. Install the software. Agree on a standard procedure (see. chapter 3) and stick to it. 1.2.2 Important settings for the camera The following tips will assure the best possible image quality for dermatoscopic photography: • Date / Timesettings: This is important for good documentation later. • Pixel Density: The greater the density, the better the resolution and the higher the capacity needed to store the image. • Sensitivity and aperture selection: Always use the same sensitivity for photography to ensure that the images which result are of similar colour.

5

1.2.3 Ideal conditions for photography in the exam room The ideal exam room should have a free-standing examination couch and neutral-coloured bright ceiling lights. This is important to optimize camera exposure and lighting parameters and will give high-contrast whole-body images in the automatic mode. In general, an exam room provides enough light, but an additional exam light such as the HEINE® HL 5000 is useful if the subject is not well-lit. A PC placed close to the top end of the couch makes it easier to compare new images with those made in previous sessions and to explain them to the patient. 1.2.4 The ideal equipment The following equipment is recommended for digital documentation of lesions: • HEINE DELTA® 20 / DELTA® 20 Plus Dermatoscope with NT 300 charger and BETA rechargeable handle. • HEINE photo adaptor to connect the camera to the dermatoscope. • Digital SLR camera with at least 3 mio pixel. • Compact Flash memory card (1 GB or more). • Card reader for a simple transfer of data to your PC. • PC with enough storage capacity. • CD-Rom for storage and data security: You can store up to 1000 to 2000 images on a CD, depending on file size. • A second charged battery for the camera as a back-up. Recommended additional equipment: • Camera Tripod • TV-Graphic Card for your PC to give you an instant view of the image on the screen. This uses the signal from the digital camera to generate and show the image. • Video extension cord. • A good colour printer. • Internet connection. • A HEINE adaptor cord.

1.3 Pre-selected camera settings The camera offers a basic choice between two different settings: 1. Automatic for full-body photos: This is ideal for full-body or torso photography with the standard lens. The flash operates automatically. 2. Manual: For dermatoscopic photography without flash and with manual white balance adjustment.

6

1.3.1 Full-body photos with the standard lens We recommend using the maximum resolution. This is useful for recognizing important details like a change in the shape of a nevus. For full-body photos we recommend at least 3mio pixels (Fig. 3). In Fig.4 you see a magnified detail from Fig.3 ( Fig.3 was taken using a high pixel setting and this makes recognition of details of the nevus possible). If the camera is used on automatic, the colour usually corresponds to the normal visual colour impression of the body. If not, there may be some colour shift caused by the room lighting. For full-body photos you need good lighting. The usual distance from the patient is about 1m, the photo format can be selected with the camera Zoom. Most photos are made in the standing position without a tripod, looking down at the patient at an angle of about 45°.

Fig. 3 Full-body image ( 2048 x 1360 Pixel)

Fig. 4 Marked detail, enlarged to maximum

1.3.2 Dermatoscopic Photos You should always take a torso or full-body photo before dermatoscopic photography and, when photographing several nevi, always record the order in which they are made (see 2.3). Dermatoscopic photos can be made in the auto mode, but the best quality is achieved in the manual mode (Fig. 5). The following settings have produced good results in the past: For Canon SLR-Adaptor

For Nikon SLR-Adaptor

For Olympus SLR-Adaptor

• ISO: 400 • Program: TV • Exposure: 1/40 s • White balance: manual

• ISO: 400 • Program: M • Exposure: 1/40 s • White balance: manual

• ISO: 400 • Program: S • Exposure: 1/40 s • White balance: manual

It is important to stick to the selected order of dermatological photography and to use the same procedure in follow-up exams. This will avoid confusion or mistakes in attributing the lesions to their respective images.

7

Fig. 5 Dermatoscopic image

1.4 Colour correction The human eye adapts automatically to ambient light (colour temperature), so that gray or white objects always appear as neutral. The digital camera needs help to be able to adapt, but is able to measure the colour temperature and can correct for this with the help of pre-selected correction or adjustment, the so-called “white balance”. The HEINE DELTA® 20 / DELTA®  20 Plus Dermatoscope features special white LEDs which produce light, the colour temperature of which is close to daylight. Slight variations in tone can occur and, in rare cases, lead to a slight shift in colour. Most cameras do not have a pre-set white balance setting for white LEDs. Those which have a manual white balance control can be set to allow for this as described in the camera instructions. To do this, please use a white card or paper. Please note: 1) To carry out a manual white balance, be sure to have the camera fitted with the photo adaptor and the DELTA 20 / DELTA 20 Plus Dermatoscope ( see 1.1). 2) For best results, we recommend that each DELTA 20 / DELTA 20 Plus Dermatoscope should be set up in this way to ensure that the images produced by each instrument are directly comparable. To avoid variations in colour between the image on the PC screen and those produced on your printer, we recommend the use of standardized reference colour charts which are available from your local camera dealer both in paper or digital form.

8

1.5 Focusing Ideal conditions for the best results in the autofocus mode are good lighting and a lesion which has a high-contrast structure. If this is not the case, we recommend the following steps to ensure good results: In full-body photos with the standard lens, the camera may focus on some high-contrast object close to the patient rather than on the patient, e.g. a patterned wall or tiled floor. Ideally, the patient should be photographed on a neutral white background such as a paper couch roll.

2. Documentation of the skin surface Photo-documentation and systematic observation of lesions over time makes early diagnosis of malignant melanoma possible. The amount of work involved varies from patient to patient. In some cases, it may only be necessary to document part of the body and, in others, it may make sense to document the whole body. The main difference in the work involved can be summarized as follows: • A torso or part-documentation involves just a small number of nevi. • A full-body documentation may be necessary and justified with high-risk patients to ensure early diagnosis of malignant melanoma. Both of the above must be part of a systematic work-flow pattern (see appendix 2) to ensure that the images are correctly-stored and can be retrieved easily. Important elements of this structure include: • The suspect nevi should be identified and marked by the dermatologist. • The order inwhich the nevi are photographed must be agreed. • Dermatoscopic photos. • Full-body and / or torso photos should be taken. • A body map should be made.

2.1 The suspect nevi should be identified and marked by the dermatologist. The suspected nevi should be marked on the patient’s body and recorded on the body-map (see appendix 1). To simplify later identification, the order of photography should be recorded on the bodymap as follows: • Linear and horizontal, • From left to right, • From top to bottom and • From back to front, starting upper left on the patient’s right front side. All the suspect nevi should be marked and numbered and the body-map should be given an identification number (see Fig.14, e.g. Nr.10927) and photographed. 2.2 Torso Documentation Torso documentation involves at least two photos: • An overview of the relevant part of the body. • At least one dermatoscopic and one close-up clinical photo of the nevus.

9

2.3 Full-body Documentation In [6] we include a description of a system to document the whole body with 24 photos. This method is demanding in terms of the work and photographic skills and equipment available to the examiner. The following describes a less-complicated method which also gives complete documentation of the body with 8 photos. It involves 4 photos of the patient lying on his back and 4 on his stomach in the following order: 1. Front right upper (Fig. 6), 2. Front right lower (Fig. 9), 3. Front left lower (Fig. 7), 4. Front left upper (Fig. 10), 5. Back left upper (Fig. 8), 6. Back left lower (Fig. 11), 7. Back right lower (Fig. 12), 8. Back right upper (Fig. 13). The patient should lie on the couch in the appropriate position for both sets of 4 photos. The upper body region extends from the neck to the hips.The lower body region extends from above the hips to the toes. To ensure patient anonymity, the face is not included. Depending on the position of the lesions, the patient positions may need to be changed slightly. It is essential that all lesions are photographed. The order of photography should also be adhered to in the case of follow-up exams to simplify comparison of the nevi with earlier images.

10

Fig. 6 Front right upper

Fig. 7 Front left lower

Fig. 8 Back left upper

Fig. 9 Front right lower

11

Fig. 10 Front left upper

Fig. 11 Back left lower

Fig. 12 Back right lower

Fig. 13 Back right upper

12

Fig. 14 Example of a marked and numbered body-map of patient 10927

2.4 Image management without special software The image management system must provide reliable identification of the individual nevi with regard to: • The patient • Date the photo was taken • Location on the body A structured sub-file should be created for each patient with the patient’s identification Nr. (e.g. patient Nr.10927 as in Fig.14). The date on which follow-up images are made can be noted as a suffix to the patient file or can be indicated by a letter e.g. 10927c for the third follow-up exam. Additionally, a new master file should be created at the beginning of every new year. The identification of the nevus and its position is assured by the body-map and the full-body images. The full-body and dermatoscopic images and the body-map should be attributed to the appropriate file and the images named accordingly. 2.4.1 Identification of files by name The following standard format guarantees the identification and location of a nevus during subsequent exams: WXXXXXYZZ W

= a (first follow-up exam) = b (second follow-up) etc. XXXXX = Patient Nr. Y = n (dermatoscopic photo - nevus) = b (body-map) ZZ = image Nr. (number of the nevus on the body-map)

13

In Fig. 15 we give an example of documentation of a part of the body in a file structure.

2.5 General software for photo-documentation Many manufacturers offer documentation software with the following functions: • Titles or descriptive texts on or next to the image • Zoom function • Comparison of two images next to each other • Contrast enhancement Some digital cameras include a simple software program of this kind.

14

3. Work-flow in documentation Appendix 2 includes a poster showing a typical work-flow chart.

4. Literature Dermatoscopy books and atlases [1] Farbatlas der Dermatoskopie Stolz, W., Braun-Falco, O., Bilek, P., Burgdorf, W., Landthaler, M. 2. Edition, 2002, Blackwell [2] Dermatoskopie von Hauttumoren. Auflichtmikroskopie – Dermoskopie – Digitale Bildanalyse Blum, A., Kreusch, J.F., Bauer, J., Garbe, C. 2003 with CD-ROM. Steinkopff Verlag, Darmstadt [3] Auflichtungsmikroskopie und Sonographie in der Dermatologie. CD – ROM Bruckbauer, H. for Windows 9.x/NT4/2000 or MacOS Ecomed Verlag, 2002 [4] Auflichtmikroskopische Vitalhistologie Dermatologischer Leitfaden Schulz, H. Springer Verlag 2002 [5] Kompendium der Dermatoskopie nach Stolz, W., Heine Optotechnik Publications: [6] Total-body photographs of dysplastic nevi Slue W, Kopf AW, Rivers JK. Arch Dermatol 1988; 124 (8):1239-1243 [7] Systematic digital body photographs for surveillance and early detection of skin cancer in teledermatology Kirchesch, H. Abstracts of: Skin Cancer and Photoaging Meeting, Rome - April 4-6, 2002 Exp Dermatol Volume 11 Issue 1 Page 96 - February 2002 [8] Die Anwendung digitaler Fotodokumentations-Verfahren bei onkologischen Patienten in der dermatologischen Praxis 12. Jahrestagung der Arbeitsgemeinschaft Dermatologische Onkologie, Erfurt Kirchesch, H., Eichhorn, A. Akt Dermatol Aug/Sept 2002, 28, p 323

15

5. Appendices Appendix 1: Full-body map Fig 16 shows the body-map. This can be photographed and used as a matrix for computer image documentation.

Fig. 16 Body-map

Appendix 2: Work-flow chart for photo-documentation. The poster shows a typical work-flow chart for digital photo-documentation. The references to the various sections of the text are useful for training purposes.

16

Work-flow chart for photo-documentation (Originator: H. Kirchesch, 2002 [8]) Who is involved? Patient Dermatologist Patient is prepared, good room lighting (1.2.3.)

x

x

Visual exam with DELTA 20

x

x

Suspect nevi marked (2.)

x

x

Body-map available?

No

Body-map: take photos and print (app. 1)

Member of staff

x

Yes

Experienced staff? (1.2.1)

No

Further documentation by Dermatologist

Yes Further documentation by staff

x

x

(x)

Body-map: Record exact position of nevi (2.1)

x

x

(x)

x

x

(x)

Body-map: Record the patient number (2.1)

x

x

(x)

Photograph completed body-map (2.1)

x

x

(x)

Select camera settings for fullbody or torso photos (1.3.1)

x

x

(x)

x

x

(x)

x

x

(x)

x

x

(x)

x

x

(x)

Body-map: record nevi in the right order (2.1)

Torso documentation (2.2) ?

Carry out follow-up exams in the same order ! ! ! (2.1)

No

Full-body documentation: 8 photos (2.3)

Yes Torso photos (1.3.1) Select camera settings for dermatoscopic photos (1.3.2 and 1.4)

Take dermatoscopic photos in the right order

No

Check image quality on screen or camera monitor

x

Image Quality OK?

x

Yes Prepare: - Patient identity - Image transfer to PC - Re-name files (2.4 and 2.4.1)

x

(2.4 and 2.4.1) und 2.4.1) If required,(2.4 compare with previous images with the patient (2.4.1)

(x)

END

17

x

(x)