Dermatology diagnostics \u2013 skin surface microscope / dermatoscope head
Certifications
Conforms to applicable European Medical Device Directive requirements (93/42/EEC) and carries CE marking for medical devices (per manufacturer’s documentation at time of marketing).
Designed and manufactured under quality systems compliant with relevant ISO and regulatory standards for medical devices.
Intended for professional medical use as a diagnostic instrument.
Conforms to applicable European Medical Device Directive requirements (93/42/EEC) and carries CE marking for medical devices (per manufacturer’s documentation at time of marketing).
Designed and manufactured under quality systems compliant with relevant ISO and regulatory standards for medical devices.
Intended for professional medical use as a diagnostic instrument.
Dermatology diagnostics \u2013 skin surface microscope / dermatoscope head
Description
The Welch Allyn EpiScope® Skin Surface Microscope is a 3.5 V skin surface microscope (dermatoscope head) designed to aid in the early detection and assessment of pigmented skin lesions and moles. It features a precision, achromatic 10x magnification optics system with integrated illumination to provide crisp, clear visualization of lesion borders and pigment patterns. The instrument includes an autoclavable contact plate with a measurement reticle to facilitate accurate sizing and objective tracking of lesion growth over time. The EpiScope head fits any 3.5 V Welch Allyn power source, allowing easy integration with existing Welch Allyn otoscope/ophthalmoscope handles and wall transformers for facility standardization. It is intended for use by healthcare professionals in dermatology, primary care and other clinical settings where evaluation of suspicious pigmented lesions is required.
Bnefits
Provides 10x magnification with precision, achromatic optics for crisp, detailed visualization of pigmented skin lesions.
Integrated illumination and optical design support assessment of lesion borders and pigment patterns, aiding early detection of suspicious lesions and moles.
Autoclavable contact plate helps reduce the risk of cross-contamination between patients.
Reticle contact plate allows measurement of lesion size and facilitates objective tracking of lesion growth over time.
Fits any 3.5 V Welch Allyn power source, enabling use with existing Welch Allyn handles and wall transformers and supporting equipment standardization.
Large, easy-to-grip focusing ring helps clinicians quickly achieve sharp focus at the skin surface.
Compact and lightweight, making it suitable for routine clinical use in dermatology, general practice and outpatient settings.
From an established manufacturer of diagnostic instruments, with compatible accessories and service support.
Indications
Visual examination and assessment of pigmented skin lesions, including moles, lentigines and other melanocytic lesions.
Assistance in distinguishing between benign and potentially malignant pigmented lesions, such as suspected basal cell carcinoma or malignant melanoma, as part of a clinical dermatological examination.
Monitoring and measurement of lesion size over time to track growth or change in suspicious skin lesions.
General dermatoscopic evaluation of skin structures at 10x magnification for dermatology and primary care use.
Composition
Precision 10x achromatic optical system housed in a durable instrument head.
Integrated illumination system designed for use with 3.5 V Welch Allyn power sources (e.g., halogen HPX or compatible lamp, depending on configuration).
Autoclavable contact plate with integrated reticle (measurement grid) for lesion sizing.
Mechanical focusing assembly with large knurled focusing ring.
Instrument body constructed from metal and high-grade engineering plastics suitable for clinical environments.
Formulation
Non-sterile reusable medical diagnostic instrument (skin surface microscope / dermatoscope head) designed for repeated clinical use with appropriate cleaning and sterilization of the contact plate.
Packaging
Single EpiScope® Skin Surface Microscope head (part number 47300) supplied as a standalone diagnostic head.
Typically supplied in a protective box or case with instructions for use (IFU) from Welch Allyn/Hillrom.
Handle and power source are usually purchased separately or as part of a diagnostic set, depending on configuration.
Usage
Use only by trained healthcare professionals in accordance with the manufacturer’s instructions for use.
Attach the EpiScope head securely to a compatible 3.5 V Welch Allyn power source or handle before use.
Ensure the lamp and power source are functioning correctly, and check the contact plate for cleanliness and integrity before examining a patient.
Apply suitable contact medium (if recommended in the IFU) to the skin or contact plate, then place the contact plate gently against the patient’s skin over the lesion to be examined.
Use the large knurled focusing ring to adjust focus until the lesion borders and pigment structures are seen clearly at 10x magnification.
Use the reticle on the contact plate to measure lesion dimensions and document size for comparison during follow-up examinations.
After use, clean the instrument according to the manufacturer’s cleaning instructions. Autoclave the contact plate as directed to reduce the risk of cross-contamination.
Inspect periodically for damage, wear, or poor image quality and replace components (e.g., lamp, contact plate) or service the instrument as recommended by the manufacturer.
Contraindications
Do not use on broken, highly infected, or heavily exudative skin lesions without following appropriate infection control protocols.
Use with caution on patients with known sensitivity to any cleaning, disinfection or contact media used with the contact plate.
Do not use if the contact plate is cracked, damaged or cannot be properly cleaned and sterilized, as this may increase the risk of cross-contamination or compromise image quality.
Avoid use if the device, optics or illumination appear to be malfunctioning or if image quality is significantly degraded.
Adverse Effects
If not properly cleaned and sterilized between patients, there is a potential risk of cross-contamination or transmission of microorganisms.
Excessive pressure on the skin may cause temporary erythema or discomfort at the examination site.
Improper handling of hot components (e.g., immediately after extended use with certain light sources) could cause minor thermal discomfort.
No systemic adverse effects are expected when the device is used correctly as a non-invasive viewing instrument.
Storage Conditions
Store the instrument in a clean, dry environment at normal room temperature, within the temperature and humidity ranges specified in the directions for use.
Protect from excessive moisture, dust, and direct sunlight.
Do not store the device where it may be subject to impact, crushing, or other mechanical damage.
Ensure the contact plate is clean and dry before storage; store with appropriate protective caps or in its case if supplied.
Follow manufacturer’s guidance on lamp storage and replacement if applicable.
Duration
Not a treatment product. The device is used intermittently during dermatological examinations for as long as clinically required over its service life, subject to appropriate maintenance and periodic inspection.
Onset
Not applicable. The EpiScope provides immediate magnified visualization and illumination when powered and applied correctly to the skin.
