HEINE DELTA one and 30 Instructions June 2020

ENGLISH

HEINE DELTA® one HEINE DELTA® 30 Please read and follow these instructions for use of and keep them for future reference.

Intended use DELTAone and DELTA 30 Dermatoscope The dermatoscope is an internally powered medical examination light for non-invasive transient contact and non-contact examination of the skin. In contact mode, skin showing a pathological change or a change due to a disease can be examined. The small contact plate is not suitable for use on mucosa. The examination of wounds is only permitted in non-contact mode. The contact plate must be removed for non-contact mode. It should only be operated by qualified medical personnel within a professional healthcare facility. The application is not limited to any patient demography. DELTAone and DELTA 30 Dermatoscope with ”Smartphone Adapter” option The ”Smartphone Adapter” option can be used to mechanically connect a smartphone with a respective app. The app is designed for documentation by recording, storing and displaying images. 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! This symbol 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! This symbol indicates valuable advice in terms of installation, operation or maintenance. Notes are important, but not related to hazardous situations. 2

Product overview HEINE DELTA® one 1 On/Off switch 2 Focusing ring 3 Contact plate 3a Contact plate small 4 Micro-USB connector 5 Charge indicator 6 Brightness control (right) 7 Polarisation button (left) 8 Polarisation indicator

HEINE DELTA® 30 9 On/Off switch 10 Polarisation button 11 Brightness control 12 Contact plate 12a Contact plate small 13 Focusing ring 14 Polarisation indicator 15 Micro-USB connector 16 Charge indicator

1

6

3

7 8

3a

4 5

12 13 10

9

11

14 16

12a

15

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Setting up Charge the instrument fully before first use. Charging Charge the device outside of the patient environment (1.5 m).

Charging via USB (DELTAone and DELTA 30) Use a USB cable to connect the USB connector (4, 15) of the dermatoscope to a USB power supply (e.g. HEINE® E4-USB, PC or laptop). Using the charging station (DELTA 30) Use the charging station to charge DELTA 30. The blue LED on the charging station indicates contact with the dermatoscope. The charge indicator is located on DELTA 30. Pay attention to the fact that no foreign objects are between the device and the charging station. When using DELTA 30, make sure that the charging station and DELTA 30 are not contaminated. The setting up and operation of the charging station is described in a separate instruction of use. Charge indicator A charge indicator (5,16) is located on the side or underside of the dermatoscope. DELTAone Instrument

Charger

switched off

connected

switched on

not connected

Battery charging full full (≥ 25 %) empty (< 25 %) residual capacity (< 10 %)

Charge indicator green, flashing green green orange orange, flashing

DELTA 30 Instrument

switched off

switched on

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Charger

connected

not connected

Battery 100 % full (99 % – 66 %) sufficiently charged (66 % – 33 %) empty (≤ 33 %) full (≥ 66 %) sufficiently charged (66 % – 33 %) empty (33 % – 10 %) residual capacity (< 10 %)

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Charge indicator segments Green - 1 Green - 2 Orange - 3 on on on flashing on on off

flashing

on

off on

off on

flashing on

off

on

on

off off

off off

on flashing

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If the device is switched off, the charge indicator remains on for a further 3 seconds and then goes off. Do not look directly into the light source when checking the charge level. Operation To switch on the illumination, press the button (1, 9) on the instrument. The device starts with the last selected brightness level and in polarisation mode. Press the button (6, 11) to adjust the brightness in three steps. The device switches off automatically after 10 minutes if the polarisation buttons or the brightness control are not used. Contact mode (with contact plate) Place the contact plate (3, 3a,12,12a) on the instrument, making sure that it snaps into place. Place the instrument with the contact plate onto the area of skin being examined. With DELTAone, extend the contact plate (3, 3a) over the focusing ring (2). When carrying out examinations with polarised illumination, you do NOT need any contact liquid such as immersion oil or disinfection spray. In polarised mode, the polarisation indicator (8, 14) lights up blue. Use the polarisation button (7, 10) to switch to non-polarised mode. In this case, use a contact fluid such as immersion oil. When using the small contact plate (3a, 12a), examination is only possible in non-polarised mode. Adjusting the focus in contact mode Your eye needs to be at a distance of approximately 2 cm from the focusing ring (2, 13). Rotate the focusing ring until you see a sharp image. The image has 10-fold magnification. Non-contact mode (without contact plate) Take off the contact plate (3, 3a,12,12a) and hold the device at a distance of approximately 1 cm above the area of skin being examined. Use the polarisation button (7, 10) to switch to non-polarised mode. Adjusting the focus in non-contact mode Your eye needs to be at a distance of approximately 2 cm from the focusing ring (2, 13). With DELTA 30, rotate the focusing ring (13) until you see a sharp image. With DELTAone, the focus is adjusted via the distance between the skin and the optics. There is no need to rotate the focusing ring (2). The image has 10-fold magnification. Smartphone Adapter To connect the dermatoscope to a smartphone, you need a suitable adapter for your smartphone. Place the adapter onto the focusing ring (2, 13). The adapter is held in place by magnetic force. Install the corresponding app on your smartphone. The app is available in the App Store*. To avoid any possible malfunctions, please deactivate all other services (switch on flight mode). *App Store is a service mark of Apple Inc.

Protecting patient data is users’ sole responsibility (e. g. protection of the smartphone with a pin, data transmission via a secure connection). Ensure that your smartphone is adequately protected against access by third parties. An electrical conducting connection between smartphone, PC and a mains power source is not permissible during the recording of the picture. All images are saved exclusively on the smartphone in the app's sandbox. The user is responsible for the regular creation of a data backup to prevent data loss, which can happen for example through deleting the app or losing the smartphone. A data backup can be made via cable to another computer or via the network to the iCloud.

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Hygienic reprocessing The instruction is available: - at www.heine.com - in a paper version which you can request from the address listed Maintenance The device is maintenance free. Service The device has no components serviceable by the end-user. 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. The expected life cycle amounts with designated use and the observation of warning and safety information as well as the maintenance instructions up to 7 years. Beyond this period, the product may continue to be used if it is in a safe and good condition. Charge your device during longer storage periods to protect the battery from deep discharge. Store and use the device only in a dry and dust-free environment. To reduce the contact temperatures in high ambient conditions, the DELTA 30 has a brightness reduction feature. General warnings Use only CE marked USB power supplies (5 V) from reputable manufacturers that conform with the safety requirements from the IEC 60950-1 Information technology or IEC 60601-1 Medical electrical equipment. Do not use power supplies where damage has been detected. 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). This product is not allowed to be entered or used in strong magnetic fields like MRI scanners. Do not modify the device. Use only original HEINE parts, spare parts, accessories and power sources. Do not look directly into the light source to avoid dazzle from the intense light. The dermatoscopes are not suitable for eye examination. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations. The appendix contains following tables - Electromagnetic disturbances – Requirements and tests - Technical specification - Explanation of the used symbols

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Electromagnetic disturbances – Requirements and tests 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 environments. Statement for the operational environments

Inside hospitals except for: near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances are high.

Performance features of the ME system that have been determined to be essential to the performance

None

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Warning

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the DELTAone/DELTA 30, including cables specified by the manufacturer. Otherwise, degradation of the performanceof this equipment could result.

A list of all cables, transducers and other accessories that are relevant for the EMC compliance

As applicable, see attachment

Test

Compliance

RF emissions CISPR11

Group 1 Class B

Harmonic Emissions

Passed*

Voltage Fluctuations/Flicker

Passed*

*n/a: ”Not applicable“ in the internally powered mode

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Technical specification DELTAone and DELTA 30 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

Technical specification DELTAone Power supply

USB 2.0 Micro B: 5 V DC, 650 mA

Power consumption

max. 3.25 W

Class

Charging: II Operation: internally powered

Charging time

typ. 75 min

Operating time

typ. 80 min at highest brightness in polarization mode

Device classification according to IEC 62471

Class 1

Applied part

Contact plate Type BF

Technical specification DELTA 30 Power supply

USB 2.0 Micro B: 5V DC, 1.2 A HEINE Charger 30

Power consumption

max. 6 W

Class

Charging: II Operation: internally powered

Charging time

USB: typ. 120 min HEINE Charger 30: typ. 120 min

Operating time

typ. 160 min at highest brightness in polarization mode

Device classification according to IEC 62471

Class 1

Applied part

Contact plate Type BF

Options USB cord with E4-USB plug-in power supply

X-000.99.303

Charger 30

X-002.99.212

Contact plate DELTAone

K-000.34.222

Small contact plate DELTAone

K-000.24.207

Contact plate DELTA 30

K-000.34.220

Small contact plate DELTA 30

K-000.34.206

Mounting case smartphone

K-000.34.26x

Universal smartphone connector

K-000.34.270

Case DELTAone

K-210.00.000

Case DELTA 30

K-230.00.000

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Hersteller Manufacturer Fabricant Fabricante Produttore Tillverkare Fabrikant Producent Produsent Valmistaja Fabricante Herstelldatum Date of manufacture Date de fabrication Fecha de fabricación Data di produzione Tillverkningsdatum Productiedatum Produktionsdato Produksjonsdato Valmistuspäivä Data de fabricação Getrennte Sammlung von Elektro- und Elektronikgeräten (Europäische WEEE Richtlinie) Product bearing this symbol may not be disposed of together with general household waste, but instead requires separate disposal according to local provisions. (European Waste Electrical and Electronic Equipment Directive, WEEE) Tri sélectif des appareils électriques et électroniques (Directive européenne DEEE) Desechado separado de aparatos eléctricos y electrónicos (Directiva Europea RAEE) Raccolta differenziata di apparecchi elettrici ed elettronici (direttiva europea RAEE) Separat insamling av elektriska och elektroniska apparater (det europeiska WEEE-direktivet) Gescheiden inzameling van elektrische en elektronische apparaten (Europese AEEA richtlijn). Separat indsamling af elektrisk og elektronisk udstyr (det europæiske WEEE-direktiv) Produkter med dette symbolet skal ikke avhendes sammen med vanlig husholdningsavfall, men krever separat kassering i henhold til lokale bestemmelser. (European Waste Electrical and Electronic Equipment Directive, WEEE) Sähkö- ja elektroniikkalaitteille tarkoitettu erillinen keräyspiste (eurooppalainen WEEE-standardi) Coleção separada de aparelhos elétricos e eletrônicos (Diretrizes Europeias WEEE) Zulässiger Temperaturbereich in °C für Lagerung und Transport Temperature limits in °C for storage and transport Plage de température admise en °C pour le stockage et le transport Rango de temperatura permitida en °C para almacenar y transportar el producto Temperatura ammessa in °C per conservazione e trasporto Tillåtet temperaturintervall i °C för lagring och transport Toegestane temperaturen in °C voor opslag en transport Tilladt temperaturområde i °C ved opbevaring og transport Temperaturbegrensning i °C for oppbevaring og transport Näyttää pakkauksen sallitun säilytys- ja kuljetuslämpötilan (°C) Limite de Temperatura em °C para armazenamento e transporte

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