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HEINE Dermatoscope Series User Manual

HEINE Dermatoscope Series
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HEINE Dermatoscopes
V-200.00.036
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HEINE Dermatoscope Series Specifications

General IconGeneral
Magnification10x
IlluminationLED
Power SourceRechargeable battery
Diopter CompensationAdjustable
Light SourceLED
PolarizationAvailable in some models
Battery LifeVaries depending on the model

Summary

HEINE Dermatoscopes

Safety and Usage Precautions

Covers essential warnings, cautions, and notes for safe and intended use of HEINE dermatoscopes.

Product Component Identification

Diagrams illustrating the parts of DELTA 20 Plus, DELTA 20 T, NC1, and mini3000 LED models.

Instrument Setup and Operation

General Instrument Setup

Instructions for attaching the instrument head to the battery holder or HEINE rechargeable handle.

DELTA 20 Plus/20T Setup

Details on attaching and locking the insert (9) to the contact plate (1) using a bayonet connection.

Contact Plate Handling

Explains the bayonet attachment and counterclockwise removal procedure for contact plates.

Dermatoscope Features and Operation

DELTA 20 Plus Brightness Control

Reduces brightness by 50% and turns off two of the four LEDs for adjustment.

DELTA 20 T Examination Mode

Enables rapid switching between polarized and non-polarized examination modes.

NC1 Contact Mode Operation

Designed for contact mode; requires removal of the magnet-attached contact plate.

mini3000 LED/XHL Skin Preparation

Moisten affected skin with HEINE dermatoscopy oil or cotton swab for examination.

Cleaning and Sterilization

General Cleaning Instructions

Clean and disinfect contact plates and instrument heads with a damp cloth and mild soap.

Recommended Cleaning Agents

Use HEINE Clean, HEINE MediClean, or disinfectant agent: quaternary ammonium compounds.

Contact Plate Reprocessing

Contact plates can be reprocessed up to 1000 cycles; follow specific cleaning and disinfection procedures.

Recommended Sterilization Methods

Autoclave at 134°C, Ethylene Oxide (EtO), or Hydrogen Peroxide (H2O2) gas plasma sterilization.

Maintenance and Troubleshooting

Changing Light Source

Procedure for changing the bulb in HEINE DELTA 20 Plus, DELTA 20 T, NC1, and mini3000 models.

HEINE mini3000 Dermatoscopes

Instructions for removing the instrument head and replacing the bulb.

General Maintenance

Instruments do not require maintenance or service; ensure proper handling.

Electromagnetic Compatibility

General EMC Guidelines

Device complies with EMC standards; avoid use near other devices that emit strong electromagnetic fields.

EMC Compliance Information

Details on compliance with specific EMC regulations and potential interference sources.

Disposal and Recycling

Product Disposal

Product must be recycled as separate electrical and electronic devices.

Disposal Regulations

Observe state-specific disposal regulations for electronic waste.

Guidance and Manufacturer Declaration

Electromagnetic Emissions

Declaration regarding electromagnetic emissions and their compliance with standards.

Electromagnetic Immunity

Declaration concerning electromagnetic immunity and recommended usage environment.

RF Exposure Information

Guidance on RF field strength, separation distances, and potential interference.

Technical Specifications

Environmental Conditions

Specifies operating, storage, and transport conditions including temperature and humidity.

Electrical Specifications

Details on nominal voltage, current, and protection class.

Classification and Applied Part

Device classification according to IEC 60601-1 and type of applied part.

Symbol Explanations

Explanation of Symbols

Provides meanings for various symbols found on the device, packaging, and manual.

CE Marking and Declarations

Explains CE marking and references to European directives for medical devices.

Handling and Storage Symbols

Manufacturer Information

Identifies manufacturer, fabrication date, and product identifiers.

Storage and Transport Conditions

Details on temperature, humidity, and pressure limits for storage and transport.

Handling and Protection Symbols

Explains symbols related to handling, fragility, and environmental protection.

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