HEINE DELTA 20 Plus Dermatoscope Instructions for Use April 2013

ENGLISH

HEINE DELTA® 20 Plus Dermatoscope Please read and follow these instructions for use and keep them for future reference. General Conditions of Warranty Instead of the statutory warranty time period of 2 years, HEINE will grant a guarantee of 5 years from the date of the consignment of the goods ex works, concerning its equipment (excluding disposables, e.g. bulbs, single-use articles, and rechargeable batteries). The guarantee covers irreproachable workmanship, on condition of the proper use of the equipment and the observation of the operating instructions. During the warranty- and guarantee time period, errors and deficiencies arising on the equipment will be rectified free of charge, in so far as such are evidenced by defective materials, processing and/or constructional errors. Should buyer complain of a material deficiency during the warranty time period, then the onus of proof is always to be on the orderer, that the product was defective already upon receipt of the goods. The statutory warranty and the guarantee do not apply to loss or damage caused by wear and tear, negligent use, the non-employment of original HEINE components and/or spares (in particular bulbs, as these have been especially developed for HEINE instruments in accordance with the following criterions: colour temperature, useful service life, safety, optical quality and performance. The statutory warranty and the guarantee do not apply to interventions by persons not authorised by HEINE or when the operating instructions are not observed by the customer. Any modification of a HEINE product with parts or additional parts which do not conform to the original HEINE specification will invalidate the warranty for the correct function of the product and further invalidate any warranty claims which result from such a change or modification. Further claims, in particular claims for replacement of loss or damage, which are experienced otherwise than directly on the HEINE product itself, are hereby excluded. 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.

Assembly of Filter insert and Contact Plate: Attach the insert 1f to the Contact Plate 1d or 1e and rotate the insert to lock the bayonet connection. Please repeat the procedure with insert 1g and Contact Plate 1a or 1b. To disassemble the filter from the Contact Plate, please reverse the procedure Attachment of Contact Plates: The contact plates (1a, 1b, 1c, 1d, 1e) are attached by a bayonet connection. To remove the contact plate turn it counterclock-wise and pull it away from the dermatoscope. To attach, reverse the procedure. Always check whether the bayonet is safely locked. Insert batteries into the handle: Please make sure that the on/off switch (7) is turned to 0. Rotate the baseplate (6) of the handle counterclockwise to open the battery cabinet. Insert the batteries (LR 14) with the plus pole facing towards the instrument head as described in the instructions of the handle. Attach the baseplate. Please follow the detailed instructions of the user manual of the HEINE BETA® handle. Please use original HEINE BETA® handles in combination with the devise. In case of using other accessories, HEINE warranty is terminated. Handling and operation The device is not suitable for eye examinations. Do not look directly into the light source to avoid dazzle from the intense, white, light emitting diodes (LED’s). It’s not allowed to modify the medical equipment. Always use the device in combination with one of the filter inserts (polarizing filter or neutral density filter). For examination of hard to reach lesions use the small contact plate (1c) in place of the standard contact plate (1a). Use DELTA 20 Plus with Immersion-Contact Plate (1a, 1b, 1c): Prepare the skin by moistening with Dermatoscopy-oil (use a cotton swab) or disinfectant spray. Turn the dermatoscope on by rotating the on/off ring (7) at the handle. Place the instrument gently so that the lesion is in the center of the contact plate.

Intended Use HEINE DELTA® 20 Plus is an epiluminescence microscope (dermatoscope) with optional polarizing filter for non-invasive visual examination of intact skin (dermatoscopy) by medical professionals.

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.

System overview

Use DELTA 20 Plus with polarizing Contact Plate (1d, 1e): When using the polarizing Contact Plate, it is not necessary to prepare the skin with liquids like dermatoscopy-oil or disinfectants. Apart from that the general operation is the same as the procedure described above.

For Dermatoscopy, use the instrument only with the HEINE contact plate (1a, 1b) correctly-fitted.

Brightness Control: The voltage-regulating 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 recommended adaptor from the digital camera adaptor range. 1a Contact plate Immersion (N) with scale 1b Contact plate Immersion (N) without scale 1c Contact plate small 1d Contact plate Polarisation (P) with scale 1e Contact plate Polarisation (P) without scale 1f Polarizing insert 1g Neutral density insert

2 Light reduction 3 Focus ring 4 Camera indicator 5 Rest channel 6 BETA handle (opt) 7 Dimmer 8 Compendium 9 Dermatoscopy-oil

Setting up the HEINE DELTA® 20 Plus Electrical and mechanical compatibility of the HEINE DELTA® 20 Plus Dermatoscope can be assured only when used in conjunction with 2.5V and 3.5V HEINE BETA® battery or rechargeable handles with HEINE AV or TL-connectors (with BETA extension piece 4.5V). Connecting DELTA 20 Plus with a handle: Hold the HEINE handle with one hand. Rotate the chequered interlock ring counterclockwise with your thumb and index finger of the same hand. Push DELTA 20 Plus into the lock and release the chequered ring. To remove, reverse the procedure. Please always check whether the instrument head is safely locked.

Hygienic Cleaning / Processing The contact plates have to be cleaned and /or disinfected after operation. Preparation: Detach the contact plate from the instrument head. Remove the instrument head from the handle. Cleaning: Wipe down the instrument head with a damp cloth (soaked in plain water, no added agents). Then rub dry. The device may be damaged by liquids. It must not be rinsed in running water or immersed in water. For cleaning of the contact plate remove the corresponding filter insert from the contact plate. Rinse the contact plate in running water using a detergent. Then rub dry with a lens cleaning cloth. If necessary, wipe the filter insert carefully with a dry cloth. The contact plate may be scratched by using improper cleaning clothes. Only use cleaning cloths that are suitable for optical lenses.

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Disinfection: Wipe the instrument head following the cleaning with disinfectant. Immerse the contact plate in disinfectant following the cleaning. The disinfectants on the basis of Alcohol (70%) may be used and must be approved for use with medical equipment made of plastic or chrome. The instrument head may be damaged by spraying disinfectant. Due to a capillary effect the disinfectant penetrates into the interior of the device. This results in reduced strength of the plastic, in reduced brightness and – in case of excessive strain, in damage of the housing. Therefore never spray on the instrument. Sterilization: The standard contact plates (1a, 1c, 1d, 1e) can be sterilized once they have been removed from the instrument (steam sterilization; 134°C / 5 min). Steam sterilization of the instrument, the filter inserts (Polarizing and Neutral Density) as well as the small Contact Plate (1c) is not allowed. The contact plate should only be sterilized after the treatment of high risk patients given that the durability of the contact plate is reduced by sterilization. Maintenance The device does not require any regular maintenance.

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. The ME device is intended for use by medical professionals in the electromagnetic environment specified below. The user of the ME device should assure that it is used in such an environment. The use of accessories, converters or cables other than the ones specified by HEINE might lead to increased emission reduced electrical immunity of the medical equipment. The ME device may not be stacked directly near or used directly beside other devices. If the ME 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. Guidance and manufacturer’s declaration – electromagnetic emissions The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such environment. Emission test

Compliance

Electromagnetic environment – Guidelines

RF emissions CISPR11

Group 1

EUT 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 EUT 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. Warning: This device is intended only for use by medical professionals. This is a device of class A CISPR 11 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 MEG or restrict the connection to the site.

Harmonic Emissions IEC 61000-3-2

Class A

Symmetrical three-phase EUTs and other EUTs.

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

Passed

Service The device does not require regular service. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant statespecific disposal regulations. Recycle batteries separately. Technical specification Magnification: 10x to 16x (depending on distance) Focal Range (correction): ca. +/- 6D Light source: LED Group “exempt” (acc. IEC 62471) Approved operating conditions Temperature: +10°C to + 35°C Humidity: 10% to 75% r.h. Air pressure: 700 hPa to 1060 hPa Weight (without handle): 180g Contact plates: Manufactured from multi-coated Silica Glass Power range: DC 2.5 V – 4.5 V Environmental conditions for storage and transport Temperature: -20°C to +50°C Humidity: 10% to 95% r.h. Air pressure: 500 hPa to 1.060 hPa General Notes and Warnings Do not use the device near strong magnetic fields like MRI scanners. Use the device only in a dry environment. Do not use the device in a potentially explosive atmosphere or with oxygen rich environment. For safe operation only use power sources which are designed and specified by HEINE for medical applications. Check the correct operation of the device before usage. Do not use the equipment if it shows visible signs of damage. Avoid direct contact between patients and plug connection of the BETA handle. Avoid dropping the device from great height. It can cause damage to the product. The performance and safety of the device can only be guaranteed when fitted with original HEINE accessories and HEINE spare parts. Otherwise the warranty is terminated. DELTA 20 Plus is a precise optical instrument. Please handle DELTA 20 Plus with care.

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Guidance and manufacturer declaration - Electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT 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 ME device requires continued operation during power mains interruptions, it is recommended that the EUT 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 EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment Guidelines

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 V eff

Radiated HF IEC 61000-4-3

3 V/m 80MHz to 2,5GHz

3 V/m

Portable and mobile RF communication equipment should be used no closer to any part of the EUT, 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 EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EUT. 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 EUT The EUT is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the EUT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the EUT 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.

Explanation of utilized symbols The following symbols are used on the device or on the packaging: The CE mark indicates that the product complies with the European medical device directive 93/42/EEC. REF

Catalogue- or reference number

SN

Serial number Manufacturer Date of manufacture 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) Temperature limits in °C for storage and transport Temperature limits in °F for storage and transport Humidity limitation for storage and transport Pressure limitation for storage and transport Type BF applied part Follow instructions for use! (Background: blue, foreground: white.) Fragile, handle with care! Keep dry Interference may occur in the vicinity of equipment marked with the following symbol “Grüner Punkt” (country-specific)

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Manufacturer: HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 · 82211 Herrsching · Germany www.heine.com Patents: www.heine.com