HEINE mini 3000 - User Manual

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HEINE mini 3000
®
LED Dermatoscope
Please read and follow these instructions for use carefully 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). Date of consignment means that HEINE hands the goods over to the
transport carrier, freight forwarder or any other person designated by the Customer for the transport of the goods
without loading the collecting vehicle.
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:
Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner!
Intended Use
The HEINE mini 3000
®
LED Dermatoscope is a epiluminescence microscope (dermatoscope) for non-invasive
visual examination of intact skin (dermatoscopy) by medical professionals.
Warnings and Safety Information
CAUTION! Indicates potentially hazardous situations. Ignoring the corresponding instructions may lead
to dangerous situations of mild to moderate extent. (Background: yellow; Foreground: black)
NOTE! Indicates valuable advice in terms of installation, operation, maintenance or repair. Notes are
important, but not related to hazardous situations.
Product overview
1a Contact Plate
1b Small contact plate
2 Ocular
3 Focusing ring
4 Light port
5 Handle head
6 Slide switch 1/0
7 End cap
8 LED light source integrated
in instrument thread
ENGLISH
6
7
5
4
1b
1a
2
3
8

Summary

General Conditions of Warranty

Intended Use

Warnings and Safety Information

Setting up the HEINE mini 3000 LED Dermatoscope

Operation of the HEINE mini 3000 LED Dermatoscope

Removing the contact plate

Instructions for detaching and reattaching the contact plate, including the small plate.

Cleaning and disinfection

Battery handle cleaning

Guidance on cleaning the battery handle with a damp cloth and appropriate detergents.

Maintenance

Changing the light source

Information that the LED light source cannot be changed by the user.

Service and Disposal

Technical Specifications

General Notes and Warnings

Electromagnetic Compatibility (EMC) Guidance

Electromagnetic Emissions

Manufacturer's declaration regarding RF and harmonic emissions and voltage fluctuations.

Electromagnetic Immunity

Manufacturer's declaration on immunity to electrostatic discharge, transients, surges, and magnetic fields.

RF Communication Equipment Separation Distances

Recommended separation distances for portable and mobile RF communication equipment.

Explanation of Utilized Symbols

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features
5. Cleaning and Disinfection
6. General Warnings
7. Disposal

The HEINE mini 3000® LED Dermatoscope is an epiluminescence microscope designed for non-invasive visual examination of intact skin (dermatoscopy) by medical professionals. It is a precise optical instrument that should be handled with care and cleaned at regular intervals.

Function Description:

The dermatoscope utilizes an LED light source for illumination and provides approximately 10x magnification (depending on distance) for detailed skin examination. It features a focusing ring (3) to adjust the image clarity and can be used with either a standard contact plate (1a) or a small contact plate (1b) for examining inaccessible lesions. The device is powered by two AA/LR6 alkaline batteries or one HEINE mini 2Z rechargeable battery.

Important Technical Specifications:

• Nominal voltage: 3V DC
• Nominal current: typ. 220mA
• Protection class: Internal power supply, Type BF applied part
• Device classification according to IEC 62471:2006: Exempt
• Battery Type: 2 Alkaline (1.5 V), size AA/LR6 or 1 HEINE mini 2Z (rechargeable with HEINE® mini NT)
• Magnification: approx. 10x (depending on distance)
• Focal Range (correction): approx. +/- 4dpt
• Contact plates: Silica glass, multi-coated
• Environmental conditions for operation: 10°C to 35°C, 30% to 90% rel. humidity, 800hPa to 1060hPa
• Environmental conditions for storage and transport: -20°C to 50°C, 10% to 95% rel. humidity, 500hPa to 1060hPa
• Dimensions (L x B x H) for head and handle: 165 x 52 x 35 mm³
• Weight: ca. 195g (incl. 2 batteries)

Usage Features:

To set up the device, the instrument thread (8) is screwed onto the handle head (5). Batteries are inserted by unscrewing the end cap (7) and placing two AA/LR6 alkaline cells with the plus contact facing the handle head. The device is switched on by sliding the switch (6) down to position "1" and off by sliding it up to "0" or clipping it over a coat pocket. Upon activation, the brightness softly increases to 100% and then adjusts based on the battery charge. A significant drop in brightness or flashing indicates the need for battery replacement.

For operation, the affected skin should be moistened with HEINE dermatoscopy oil or a comparable substance. The device is placed gently over the lesion with the contact plate (1a) centered. The examiner's eyes should be close to the ocular (2), and the focusing ring (3) is adjusted with a free hand to obtain a clear image. The focusing ring's adjustment can be controlled using the scale on top of the dermatoscope.

The contact plate (1a) is attached by a bayonet fitting and can be removed by rotating the knurled ring counter-clockwise. The small contact plate (1b) is a push-fit and can be used for inaccessible lesions; it is removed by holding the knurled housing and pulling off without twisting. When replacing, ensure the light-port (4) faces the bulb/LED.

Maintenance Features:

The device does not require any regular maintenance. The LED light source is integrated and cannot be changed. Repairs should only be performed by qualified personnel, and the device should not be opened or modified.

Cleaning and Disinfection:

The contact plate (1a) can be removed and sterilized or disinfected using routine methods such as disinfectant solution, washing, boiling, or autoclaving (up to 134°C for 5min). Sterilization should be reserved for risk patients as it reduces durability. The small contact plate (1b) and the dermatoscope can be cleaned by wiping with a damp cloth soaked in alkaline or pH-neutral cleaning agents. For disinfection of the outer surface of the instrument, wipe disinfection with medical device-approved detergents is recommended. The battery handle can be cleaned with a damp cloth (e.g., alkaline or pH-neutral detergent), and wipe disinfection with medical device-approved detergents is recommended for its outer surface. Disinfection by spraying or immersion, as well as sterilization, is not allowed for the instrument itself as it will cause damage.

General Warnings:

• Always check for visible signs of damage before use.
• Do not use in hyperbaric chambers, explosive, or oxygen-loaded environments.
• Avoid using near strong magnetic fields like MRI scanners.
• Do not look into bright light sources with loupes to prevent glare.
• Only use original HEINE accessories and spare parts to ensure performance and safety, otherwise, the warranty is terminated.
• Do not modify the device. If modified, ensure its safe use through investigations and tests.
• Store and use the device in dry and dust-free environments. Remove batteries if not used for extended periods.
• The HEINE mini 3000® LED Dermatoscope is not allowed to be used for eye examinations.

Disposal:

The product must be recycled as separated electrical and electronic devices, observing relevant state-specific disposal regulations.

HEINE mini 3000 Specifications