HEINE Dermascopes Instructions for Use July 2020

ENGLISH

HEINE Dermatoscopes These instructions apply to the following products of the HEINE Dermatoscope series: HEINE NC1 Dermatoscope, HEINE DELTA 20 Plus Dermatoscope, HEINE DELTA 20T Dermatoscope, HEINE mini3000 LED Dermatoscope, HEINE mini3000 Dermatoscope. Please read and follow these instructions for use of and keep them for future reference. Intended Use The HEINE dermatoscopes are internally powered medical examination lights. It is an reflected-light microscope for non-invasive, visual inspection of intact skin by a healthcare professional. The diagnostic is not limited to any patient demography. For U.S. only: Federal law restricts this device to sale by or on the order of a Physician or Practitioner! Warnings and Safety Information Caution! Indicates potential hazardous situations. Ignoring the corresponding instructions may lead to dangerous situations of mild to moderate extent. (Background color yellow, foreground color black.) Note! Note indicates valuable advice in terms of installation, operation, maintenance or repair. Notes are important, but not related to hazardous situations. Product overview HEINE DELTA 20 Plus and HEINE DELTA 20T Dermatoscope

Setting up To set up the instrument, screw the instrument head into the HEINE battery handle or plug it on the HEINE rechargeable handle. HEINE DELTA 20 Plus and HEINE DELTA 20T Dermatoscope Assembly of filter insert and contact plate Attach the insert (9) to the contact plate (1) and rotate the insert to lock the bayonet connection. To disassemble the filter (9) from the contact plate, please reverse the procedure. Attachment of contact plate The contact plates (1 and 8) are attached by a bayonet connection. To remove the contact plate turn it counterclockwise and pull it away from the dermatoscope. To attach, reverse the procedure. Always check whether the bayonet is safely locked. Operation HEINE DELTA 20 Plus Dermatoscope For examination of hard to reach lesions use the small contact plate (8) in place of the standard contact plate (1). Use DELTA 20 Plus with immersion contact plate (1a, 1b, 8) Prepare the skin by moistening with HEINE dermatoscopy-oil (use a cotton swab) or disinfectant spray. Turn the dermatoscope on by rotating the on/off ring (7) at the handle. Gently place the instrument so that the lesion is in the center of the contact plate. The examiner’s eye should be as close to the eye-piece (3) as possible. Adjust the focus ring until a crisp, clearly-focused-image is obtained. Always use the device in combination with one of the filter inserts (polarizing filter or neutral density filter). Only use contact plates from HEINE. Using the DELTA 20 Plus with polarizing contact plate (1c, 1d) When using the polarizing contact plate, DO NOT prepare the skin with liquid like dermatoscopy-oil or disinfectants. Apart from that the general operation is the same as the procedure above.

1 Contact plate 1a Contact plate immersion (N) with scale 1b Contact plate immersion (N) without scale 1c Contact plate polarisation (P) with scale 1d Contact plate polarisation (P) without scale 1e Contact plate DELTA 20T with scale 1f Contact plate DELTA 20T without scale 2 Changeover to 2 LEDs 3 Focus ring

4 Camera indicator 5 Fixation groove 6 BETA handle (optional) 7 Dimmer 8 Contact plate small 9 Filter insert 9a Polarizing insert 9b Neutral density insert 9c DELTA 20T filter insert

HEINE NC1 Dermatoscope 10

HEINE DELTA 20T Dermatoscope The DELTA 20T allows for a rapid change from polarized to non-polarized examination mode over a side switch. Application remains the same as the DELTA 20 Plus with the immersion contact plate (see above). A difference is that no immersion fluid is required in the polarized examination mode.

10 Focusing ring 11 Contact plate

11

Brightness control The voltage regulation electronics of the HEINE DELTA 20 Plus Dermatoscope guarantee constant brightness. Pressing one of the two buttons on the instrument (2) will reduce the brightness by 50% and will turn off 2 of the 4 LED’s resulting in lateral illumination for improved contrast when viewing the pigmented structure. An electrical conducting connection between camera, PC and a mains power source is not permissible. For documentation with a digital camera only, use the HEINE photo adaptor and our recommend adaptor from the digital camera adaptor range.

HEINE NC1 Dermatoscope The device can be used in non-contact modus. To do this, the contact plate, which is attached through magnets, must be removed. Hold the device approximately 2 cm above the skin area to be examined. Bring your eye towards the eye piece (10) as close as possible and adjust the eye piece focus until a sharp image is achieved. HEINE mini3000 LED/XHL Dermatoscope 15

17

12 Contact plate 13 Contact plate small 14 14 Ocular 15 Focusing ring 12 18 16 Light port 17 Handle head 18 Slide switch 1/0 19 End cap 20 LED or XHL light source integrated in instrument head 20 16

13

Contact modus (with contact plate) See HEINE DELTA 20 Plus Dermatoscope with polarizing contact plate. An extra lens is integrated in the contact plate (11) which provides a 9 x magnification when the contact plate is connected. Without the contact plate, a 6 x magnification is achieved. HEINE mini3000 LED/ XHL Dermatoscope Moisten the affected skin with HEINE dermatoscopy oil or comparable with a cotton wool swab. Switch on the device and place it gently over the lesion, so that it is in the center of the contact plate (12). The examiner’s eyes should be as close as possible to the ocular (14). With the free hand adjust the focusing ring (15) until a clearly focused image is obtained. Using the scale on top of the dermatoscope you can control the adjustment of the focusing ring. In most cases it is only necessary to set up the focus once.

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Removing the contact plate The contact plate (12) is attached by a bayonet fitting. To remove, simply rotate the knurled ring counterclockwise and detach from the dermatoscope. The small contact plate (13) can be used instead of the contact plate (12) for the examination of inaccessible lesions. To remove it, simply hold the knurled housing and pull off without twisting. When replacing, make sure that the light port (16) faces the bulb/LED. HEINE dermatoscopes are intended for a brief examination of less than 10 minutes with a 20 minutes break until the next application. The setup and operation of the HEINE handles are described in a separate instruction for use. Hygienic Reprocessing Instructions on hygienic reprocessing must be adhered to, based on national standards, laws and guidelines. Classification according to KRINKO: non-critical Spaulding Classification USA: non-critical Allow the device to cool down before reprocessing. In the event of suspected contamination, the instruments should be forwarded for reprocessing immediately. The described cleaning and disinfection measures do not replace the specific rules applicable for the establishment. HEINE Optotechnik only approves the agents and procedures mentioned below. Cleaning and disinfection may only be carried out by personnel with sufficient hygienic knowledge. Observe the instructions of the manufacturer of the reprocessing media. Do not use spray or immersion disinfection, dripping wet or heavily foaming tissues. Do not use ultrasonic reprocessing. Do not use reprocessing media including alcohol. The contact plates have to be cleaned and/or disinfected after each use. They should only be sterilized after the treatment of high risk patients. The mini3000 contact plate up to 4 times max., the DELTA 20 Plus contact plate up to 25 times max. Steam sterilization of the instrument heads, the filter inserts (9), the small contact plates of the DELTA 20 Plus and DELTA 20T (8), of the mini3000, mini3000 LED dermatoscope (13) and the contact plate of the NC1 dermatoscope (11) and the DELTA 20T (1e+1f ) is not allowed. Procedure Instrument head Clean and disinfect the head of the dermatoscopes manually (clean and disinfect through wiping) Recommended agents Cleaning agent: Neodisher MediClean Disinfectant agent: quaternary ammonium compounds (e.g. Microbac Tissues)

General Warnings Check the correct operation of the device before use! Do not use the device if there are visible signs of damage or the light begins to flash. Do not use the device in fire- or explosive risk area (e.g. oxygen saturated or anaesthetic environments) Do not modify the device. Use only original HEINE parts, spare parts, accessories and power sources. Repairs shall only be carried out by qualified persons. Do not look directly into the light source to avoid dazzle from the intense light. The dermatoscopes are not suitable for eye examination. General Notes The warranty for the entire product is invalidated if non-genuine HEINE products or non-original parts are used and if repairs or modifications are made to the device by persons not authorized by HEINE. For more information, please visit www.heine.com. If you don’t use the device for a longer period of time, please remove the batteries in advance. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations. Electromagnetic Compatibility Medical electric devices are subject to special precautionary measures with regard to electromagnetic compatibility (EMC). Portable and mobile high frequency communication equipment can affect medical electric devices. This is a device in the domestic environment, this device may cause radio interference, so that it may be necessary in this case, to take appropriate remedial measures, as e.g. orientation, new arrangement or shielding of the device or restrict the connection to the site. The use of accessories, converters or cables other than the ones specified by HEINE might lead to increased emission and reduced electrical immunity of the medical equipment. The device may not be stacked directly near or used directly beside other devices. If the device is to be operated in a stack or with other devices, the device should be watched to ensure it operates properly in this location. The appendix contains following tables - Guidance and manufacturer’s declaration – Electromagnetic immunity - Technical specification - Explanation of the used symbols

Contact plates Clean and disinfect the contact plates manually after removing from the instrument head (clean and disinfect through wiping). Before cleaning or disinfection you can remove the additional lens of the NC1 dermatoscope, but you must remove the filter insert of the DELTA 20 Plus and of the DELTA 20T. Recommended agents Cleaning agent: Neodisher MediClean Disinfectant agent: quaternary ammonium compounds (e.g. Microbac Tissues) The contact plates can be reprocessed up to 1000 cycles (without autoclaving). The contact plates of the DELTA 20 Plus (1a-1d) and of the mini3000, mini3000 LED dermatoscope (12) can be sterilized once they have been removed from the instrument head and the filter inserts have been removed. Recommended programs of sterilization Steam sterilization: 132-134°C; 3 min Fractional vacuum procedure (three-times) or gravitational procedure (three-times). Changing the light source Allow the device to cool down before changing the bulb. HEINE DELTA 20 Plus, HEINE DELTA 20T, HEINE NC1 and HEINE mini3000 LED Dermatoscope The LED cannot be changed. HEINE mini3000 Dermatoscope Remove the instrument head from the handle and pull out the bulb. Wipe down the head of the new bulb with a soft cloth Insert the new bulb as far as possible into the socket. Maintenance and Service The instruments do not require maintenance or service.

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Appendix Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Emission test

Compliance

Electromagnetic environment – Guidelines

RF emissions CISPR11

Group 1

The device uses RF energy only for its internal function. Therefore, RF-emission is very low and it is unlikely that any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000-3-2

Class A

Symmetrical three-phase devices and other devices.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Passed

Guidance and manufacturer declaration - Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – Guideline

Electrostatic discharge (ESD) acc. to IEC 61000-4-2

± 6 kV contact discharge ± 8 kV air discharge

± 6 kV contact discharge ± 8 kV air discharge

Floors should be wood, concrete or covered with ceramic tiles. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for mains cables ± 1 kV for input and output lines

± 2 kV for mains cables ± 1 kV for input and output lines

The supply voltage quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV voltage phase – phase, ± 2 kV voltage phase – earth

± 1 kV voltage phase – phase ± 2 kV voltage phase – earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT, (>95% dip in UT) for 1/2 period 40% UT, (60% dip in UT) for 5 periods 70% UT, (30% dip in UT) for 25 periods <5% UT, (>95% dip in UT) for 5 seconds

< 5% UT, (>95% dip in UT) for 1/2 period 40% UT, (60% dip in UT) for 5 periods 70% UT, (30% dip in UT) for 25 periods <5% UT, (>95% dip in UT) for 5 seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered by a UPS (uninterruptible power supply) or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Comment: UT is the a.c. supply voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Immunity test Conducted RF IEC 61000-4-6

IEC 60601 test level 3 Veff 150 kHz to 80 MHz

Compliance level 3 V eff

Radiated HF IEC 61000-4-3

3 V/m 80MHz to 2,5GHz

3 V/m

Electromagnetic environment Guidelines Portable and mobile RF communication equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 3,5/3 * SQRT (P/W) d = 3,5/3 * SQRT (P/W) 80 MHz to 800 MHz d = 7/3 * SQRT (P/W) 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyaa, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80Hz and 800MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM a  radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m.

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Recommended separation distances for portable and mobile RF communication equipment and the device The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 3,5/3 * SQRT (P)

80 MHz to 800 MHz d = 3,5/3 * SQRT (P)

800 MHz to 2,5 GHz d = 7/3 * SQRT (P)

0.01

0.1

0.1

0.2

0.1

0.4

0.4

0.7 2.3

1

1.2

1.2

10

3.7

3.7

7.4

100

11.7

11.7

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Erläuterung der verwendeten Symbole Auf dem Gerät bzw. der Verpackung finden sich folgende Symbole: Explanation of utilized symbols The following symbols are used on the device or on the packaging: Explication des symboles utilisés Les symboles suivants figurent sur l’appareil ou sur l’emballage : Explicación de los símbolos utilizados Sobre el aparato o sobre el embalaje se encuentran los siguientes símbolos: Spiegazione dei simboli utilizzati Sull’apparecchio e/o sulla confezione sono presenti i seguenti simboli: Förklaring av symboler som används På enheten eller på förpackningen hittar du följande symboler: Verklaring van de gebruikte symbolen Op het apparaat resp. op de verpakking staan de volgende symbolen: Forklaring af de anvendte symboler Følgende symboler findes på apparatet hhv. emballagen: Symbolforklaring Følgende symboler finnes på enheten eller emballasjen: Käytettyjen symbolien selitys Laitteesta ja pakkauksesta löytyvät seuraavat symbolit: Explicação dos símbolos utilizados Os símbolos seguintes são usados nos equipamentos ou nas suas embalagens:

Technical specification Environmental conditions for operation

+10 °C to +35 °C 30 % to 75 % rel. humidity 700 hPa to 1060 hPa

Environmental conditions for storage

+5 °C to +45 °C 45 % to 80 % rel. humidity 500 hPa to 1060 hPa

Environmental conditions for transport

-20 °C to +50 °C 45 % to 80 % rel. humidity 500 hPa to 1060 hPa

Nominal voltage

3.0 V – 3.7 V

Nominal current

440 –760 mA

Protection class

internal power supply

IP-Code

IP20

Device classification according to IEC 6247

Group 2

Applied part

Type BF (for contact plate)

HEINE mini3000 Dermatoscope

#109 (2,5 V)

CE-Kennzeichnung kennzeichnet die Übereinstimmung mit der Europäischen Medizinprodukterichtlinie 93/42 EWG. The CE mark indicates that the product complies with the European medical device directive 93/42/EEC. Le marquage CE indique la conformité à la directive européenne 93/42/CEE relative aux dispositifs médicaux. El marcado CE indique la conformidad con la directiva europea 93/42 /CEE relativa a los productos sanitarios. Il marchio CE indica la conformità con la direttiva europea sui dispositivi medici 93/42 CEE. CE-märkning markerar en överensstämmelse med det europeiska direktivet för medicinska produkter 93/42 EEG. CE-markering duidt de overeenstemming aan met de Europese Richtlijn betreffende medische hulpmiddelen 93/42 EEG. CE-mærkningen angiver overensstemmelse med det europæiske direktiv 93/42/EØF om medicinsk udstyr. CE-merket angir at produktet er i samsvar med rådsdirektiv 93/42/EØF om medisinsk utstyr. CE-merkintä tarkoittaa, että laite vastaa eurooppalaisen lääkinnällisiä laitteita koskevan standardin 93/42 ETY vaatimuksia. O símbolo CE identifica a concordância com a Diretriz Européia para Dispositivos Médicos 93/42/CEE.

REF

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Katalog- oder Bestellnummer Catalogue- or order number Numéro de catalogue ou de commande Número de catálogo o de pedido Codice catalogo e di dell’ordine numero Katalog- eller Beställningsnummer Catalogus- of Bestelnummer Katalog- eller Ordrenummer Katalog- eller bestillingsnummer Luettelo- tai viitenumero Número de catálogo ou pedido