HEINE Dermatoscopes

Intended Use

HEINE dermatoscopes are internally powered medical examination lights. They function as reflected-light microscopes for the non-invasive, visual inspection of intact skin by healthcare professionals. The diagnostic use is not limited to any specific patient demographic.

Warnings and Safety Information

Caution! ⚠️ Indicates potential hazardous situations. Ignoring instructions may lead to mild to moderate injuries.

Note! ℹ️ Provides valuable advice for installation, operation, maintenance, or repair, but is not related to hazardous situations.

Product Overview

HEINE DELTA 20 Plus and HEINE DELTA 20T Dermatoscope

Key Components:

• 1 Contact plate: Available in various types including immersion (with/without scale), polarization (with/without scale), and specific DELTA 20T plates.
• 2 Changeover to 2 LEDs: A switch to adjust illumination.
• 3 Focus ring: For adjusting the image focus.
• 4 Camera indicator: Shows camera status.
• 5 Fixation groove: For securing components.
• 6 BETA handle (optional): An ergonomic handle for improved grip.
• 7 Dimmer: Controls the brightness of the light source.
• 8 Contact plate small: A smaller plate for examining hard-to-reach areas.
• 9 Filter insert: Includes polarizing, neutral density, and specific DELTA 20T filter inserts for enhanced visualization.

HEINE NC1 Dermatoscope

• 10 Focusing ring: For adjusting image focus.
• 11 Contact plate: The primary contact surface.

HEINE mini3000 LED/XHL Dermatoscope

• 12 Contact plate: The main interface with the skin.
• 13 Contact plate small: A compact version for specific examinations.
• 14 Ocular: The eyepiece for viewing the magnified image.
• 15 Focusing ring: Adjusts the sharpness of the image.
• 16 Light port: Allows light from the source to illuminate the examination area.
• 17 Handle head: Houses the main components and controls.
• 18 Slide switch 1/0: Powers the device on and off.
• 19 End cap: Protects the base of the instrument.
• 20 LED or XHL light source integrated in instrument head: The illumination source for the device.

Setting Up

To set up the instrument, screw or plug the instrument head into the HEINE battery handle or the HEINE rechargeable handle.

Operation

HEINE DELTA 20 Plus and HEINE DELTA 20T Dermatoscope

Assembly of filter insert and contact plate: Attach the filter insert (9) to the contact plate (1) by rotating it until the bayonet connection locks. Reverse the process to remove the filter.

Attachment of contact plate: Contact plates (1 and 8) attach via a bayonet connection. Turn counterclockwise to remove and reverse to attach. Always ensure the bayonet is securely locked.

HEINE DELTA 20 Plus Dermatoscope:

• Use the small contact plate (8) for examining hard-to-reach lesions.
• With immersion contact plate (1a, 1b, 8): Moisten the skin with HEINE dermatoscopy oil or disinfectant spray. Turn on the device by rotating the ring (7) on the handle. Gently place the instrument so the lesion is centered in the contact plate. Position your eye as close to the eyepiece (3) as possible and adjust the focus ring until a crisp image is obtained. Always use with a filter insert (polarizing or neutral density). Only use HEINE contact plates.
• With polarizing contact plate (1c, 1d): No immersion liquid is required. Operation is otherwise the same as with the immersion contact plate.
• Brightness control: The integrated electronics ensure constant brightness. Pressing buttons (2) reduces brightness by 50% and activates lateral illumination for improved contrast. Electrical connection to camera/PC/mains is not permitted. Use HEINE photo adapter for digital camera documentation.

HEINE DELTA 20T Dermatoscope:

• A side switch allows rapid change between polarized and non-polarized examination modes. Operation is similar to the DELTA 20 Plus with immersion contact plate; immersion fluid is not required in polarized mode.

HEINE NC1 Dermatoscope:

• Can be used in non-contact mode by removing the contact plate. Hold the device approximately 2 cm above the skin area. Bring your eye close to the focusing ring (10) and adjust until a sharp image is achieved.
• Contact mode: Refer to the HEINE DELTA 20 Plus with polarizing contact plate instructions. The contact plate (11) includes an extra lens, providing 9x magnification (6x without the plate).

HEINE mini3000 LED/XHL Dermatoscope:

• Moisten the skin with HEINE dermatoscopy oil or a comparable substance using a cotton swab. Turn on the device and place it gently over the lesion, centered on the contact plate (12). Bring your eye as close as possible to the ocular (14). Adjust the focusing ring (15) with your free hand until a sharp image is obtained. The focus can typically be set once for all subsequent examinations.

Removing the Contact Plate

The contact plate (12) is attached by a bayonet fitting. Rotate the knurled ring counterclockwise and detach. The small contact plate (13) can be used for inaccessible lesions; it inserts into the head. Ensure the light port (16) faces the bulb/LED when replacing.

Hygienic Reprocessing

Follow national standards, laws, and guidelines for hygienic reprocessing. Classification: non-critical. Allow the device to cool before reprocessing. Reprocess immediately if contamination is suspected. HEINE approves only specified agents and procedures. Cleaning and disinfection must be performed by qualified personnel. Observe manufacturer instructions. Do not use spray/immersion disinfection, dripping wet/foaming cloths, ultrasonic, or alcohol-based reprocessing media.

Contact plates must be cleaned/disinfected after each use. Sterilization is recommended only after treating high-risk patients (mini3000: max 4 cycles; DELTA 20 Plus: max 25 cycles). Instrument heads, filter inserts, small contact plates, NC1 contact plates, and DELTA 20T contact plates are not sterilizable.

Procedure:

• Instrument head: Clean and disinfect manually by wiping. Recommended: Neodisher MediClean (cleaning agent), quaternary ammonium compounds (disinfectant).
• Contact plates: Clean and disinfect manually, separate from the instrument head. Remove the NC1 extra lens or the DELTA 20 Plus/20T filter insert before cleaning. Recommended: Neodisher MediClean (cleaning agent), quaternary ammonium compounds (disinfectant). Contact plates can be reprocessed up to 1000 cycles (without autoclaving). DELTA 20 Plus and mini3000 LED contact plates can be sterilized after removal and filter removal. Recommended sterilization: Steam (132-134°C; 3 min) using fractional vacuum or gravitational methods.

Changing the Light Source

Allow the device to cool before changing the bulb. The LED cannot be changed for DELTA 20 Plus, DELTA 20T, NC1, and mini3000 LED models. For the mini3000, remove the instrument head from the handle, pull out the bulb, wipe the new bulb with a soft cloth, and insert it fully.

Maintenance and Service

The instruments require no maintenance or service.

General Warnings

• Check the correct operation of the device before each use. Do not use if damaged or if the light flashes.
• Do not use in fire or explosion risk areas (e.g., oxygen-saturated or anesthetic environments).
• Do not modify the device.
• Use only original HEINE parts, spare parts, accessories, and power sources.
• Repairs must be carried out only by qualified personnel.
• Do not look directly into the light source to avoid dazzle.
• Dermatoscopes are not suitable for eye examination.

General Notes

Warranty is invalidated by the use of non-genuine HEINE products, non-original parts, or unauthorized repairs/modifications. Visit www.heine.com for more information. Remove batteries if the device will not be used for an extended period.

Disposal

The product must be recycled as separate electrical and electronic equipment. Observe relevant country-specific disposal regulations.

Electromagnetic Compatibility

Medical electrical devices are subject to special EMC precautions. Portable and mobile RF communication equipment can affect these devices. This device may cause radio interference; take remedial measures such as reorientation, rearrangement, or shielding. Using non-specified accessories, converters, or cables may increase emissions or reduce immunity. Do not stack or use the device directly next to or with other devices; observe for proper operation in such configurations.

Technical Specifications

Environmental Conditions for Operation: +10°C to +35°C, 30% to 75% relative humidity, 700 hPa to 1060 hPa.

Environmental Conditions for Storage: +5°C to +45°C, 45% to 80% relative humidity, 500 hPa to 1060 hPa.

Environmental Conditions for Transport: -20°C to +50°C, 45% to 80% relative 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 (IEC 62471): Group 2

Applied Part: Type BF (for contact plate)

HEINE mini3000 Dermatoscope: #109 (2.5 V)

Explanation of Symbols

CE Mark: Indicates conformity with the European Medical Device Directive 93/42/EEC.

REF: Catalogue or order number.

Follow Instructions: Symbol indicating mandatory adherence to user instructions.

Fragile: Symbol indicating the product is fragile and requires careful handling.

Keep Dry: Symbol indicating the product should be stored in a dry environment.

Recycling Symbol (Grüner Punkt): Indicates country-specific recyclability.

UDI: Unique Device Identification.