HEINE ML4 HeadLight Kit LED mPack Plus Plug In Transformer

HEINE

Lighting

Medical Headlight / Surgical Headlight

Manufactured under a certified quality management system in accordance with ISO 13485 and ISO 9001 for medical devices.
CE Marked medical device in accordance with applicable European medical device regulations (as per HEINE Declarations of Conformity).
Designed and tested to relevant IEC/EN standards for medical electrical equipment and safety (including standards for luminaires and patient vicinity use), as documented in HEINE technical files.
LEDHQ technology incorporates controlled thermal management and long Life performance per HEINE internal qualification and reliability testing.

Manufactured under a certified quality management system in accordance with ISO 13485 and ISO 9001 for medical devices.
CE Marked medical device in accordance with applicable European medical device regulations (as per HEINE Declarations of Conformity).
Designed and tested to relevant IEC/EN standards for medical electrical equipment and safety (including standards for luminaires and patient vicinity use), as documented in HEINE technical files.
LEDHQ technology incorporates controlled thermal management and long Life performance per HEINE internal qualification and reliability testing.

Medical Headlight / Surgical Headlight

Description

The HEINE ML4 HeadLight Kit LED - mPack Plus Plug-in Transformer (catalogue number J-008.31.413) is a premium medical LED headlight system designed to provide ultra-bright, homogeneous, coaxial illumination with HEINE LEDHQ quality. Mounted on the Professional L headband and powered by the belt-worn mPack battery with plug-in transformer, it offers an adjustable spot size from 30 mm to 80 mm at a 420 mm working distance, up to approx. 90,000 lux at short working distance, and a typical colour temperature around 5,500 K for true-colour tissue rendering. The lightweight headband with multiple adjustment points and soft padding ensures a comfortable, secure fit for long surgical procedures, while stepless intensity control and adjustable angle of declination support precise, shadow-free illumination of even difficult-to-see areas.

Bnefits

Ultra-bright, homogeneous LEDHQ illumination with up to roughly 90,000 lux at short working distance for excellent visualisation of fine anatomical detail.
Adjustable illumination spot size (approx. 30 mm to 80 mm at 420 mm working distance) to adapt the light field to any examination or procedure.
Coaxial illumination design creates a shadow-free image and excellent visual access to deep or narrow cavities.
True-colour tissue rendering thanks to high colour temperature (around 5,500 K) and high colour rendering index (CRI typically >90), supporting accurate diagnosis.
Stepless light intensity control via headband-mounted rheostat allows optimal brightness settings and helps avoid glare and disturbing reflections.
Professional L headband provides multiple adjustment points and soft padding for a secure, comfortable fit during long operations or treatment sessions.
Flexible power concept with the mPack belt-worn battery and plug-in transformer provides long operating time (typically up to about 8.5 hours at full power) and convenient recharging.
LED thermal management maximises LED life (typically up to 50,000 hours) and maintains consistent light output over the lifetime of the product.
Compatible with HEINE HR/HRP binocular loupes and i-View loupe mount (available in dedicated kits), enabling combined magnification and illumination for advanced procedures.
Compact, robust German-engineered design with smooth surfaces that are easy to clean and disinfect for infection-control compliance.

Indications

Illumination for surgical and minor operative procedures across a wide range of specialties (e.g., general surgery, ENT, maxillofacial, dental, ophthalmic).
Use in dermatology and aesthetic medicine where precise, colour-true illumination of skin structures is required.
Procedures and examinations that demand continuous, high-quality lighting at close working distances, including long-duration surgeries.
Use with binocular loupes for high-precision work in dentistry, microsurgery and other fine procedures when configured as a loupe–light system.
General clinical examination in settings where a head-mounted, coaxial light source is preferable to fixed examination lamps.

Composition

ML4 LED HeadLight with integrated high-performance LEDHQ light source and adjustable aperture lever.
Professional L headband with multiple adjustment points, soft padding and integrated rheostat for intensity control.
HEINE mPack belt-worn rechargeable battery pack (mPack Plus) designed for ML4 LED HeadLight and compatible systems.
Plug-in transformer for powering and charging the mPack battery from mains supply.
Connection cabling between headlight and mPack battery pack.
Housing components manufactured from durable, lightweight materials with smooth, easy-clean surfaces.

Formulation

Product type: medical LED headlight system with belt-mounted rechargeable battery and plug-in transformer.
Illumination: typically up to approx. 90,000 lux at short working distance (manufacturer data) and up to around 50,000 lux at 250 mm depending on configuration.
Colour temperature: typically around 5,500 Kelvin neutral-white LED light for natural tissue colour reproduction.
LED operating life: typically up to 50,000 operating hours.
Spot size: adjustable from approximately 30 mm to 80 mm at 420 mm working distance via the aperture lever.
Angle of declination: stepless, individually adjustable to the user’s preferred working posture.
Control: headband-mounted rheostat for stepless brightness adjustment.
Power source: HEINE mPack belt-worn battery with plug-in transformer (mPack Plus concept); typical operating time about 8.5 hours at full power from a full charge.
Mounting: Professional L headband with coaxial LED headlight module, optionally combinable with HEINE HR/HRP loupes via i-View mount (in specific kits).

Packaging

Supplied as a complete HEINE ML4 LED HeadLight kit including ML4 LED headlight on Professional L headband, mPack belt-worn battery and plug-in transformer (exact contents as per kit J-008.31.413).
Delivered in a protective manufacturer carton or case with internal inserts to secure the headlight, power pack and accessories during transport.
Includes instructions for use, safety and maintenance information, and warranty documentation.
Outer packaging labelled with HEINE branding, product name, catalogue number J-008.31.413 and relevant markings for medical devices and electrical equipment.

Usage

Before first use, read the HEINE ML4 LED HeadLight instructions for use and the mPack power pack manual in full.
Charge the mPack battery fully using the supplied plug-in transformer, observing the charge-status indicators and manufacturer’s guidance.
Adjust the Professional L headband to fit the user’s head by setting the circumference and height adjustments; ensure the padding rests comfortably and the headband is secure but not overly tight.
Position the ML4 LED HeadLight so that the light module sits centrally above or between the eyes; lock adjustment points as described in the instructions.
Connect the ML4 LED HeadLight cable to the mPack power pack and switch the system on using the designated controls.
Use the headband-mounted rheostat to adjust the brightness steplessly to the desired level, avoiding unnecessary glare or reflections.
Set the angle of declination so the light beam follows the user’s natural line of sight to the working field, minimising neck strain.
Adjust the illumination spot size using the aperture lever on the headlight, selecting a smaller or larger spot as required by the procedure and distance.
During procedures, periodically check that the headband remains comfortable and that cables do not interfere with sterile fields or instruments.
After use, switch off the headlight, disconnect it from the power pack if required and clean/disinfect the headband and light module with approved disinfectant wipes or solutions according to HEINE’s reprocessing guidance.
Recharge the mPack after use or when indicated by the charge status display, and perform regular visual inspections of cables, connectors and housings for wear or damage.
Do not attempt to open the LED module or modify electrical components; servicing and repair should only be carried out by HEINE or authorised service partners.

Contraindications

Not intended as a substitute for certified surgical operating lights when those are required by local regulations or procedure type.
Not suitable for use in potentially explosive atmospheres or in environments that require specifically certified explosion-proof equipment, unless the complete installation has been assessed accordingly.
Should not be used if the headband, LED module, cabling, mPack battery or plug-in transformer is visibly damaged or malfunctioning.
Use with caution in patients who are extremely light-sensitive or where intense light exposure of certain tissues is contraindicated.
The device is not intended for direct intraocular illumination at very short distances without adherence to applicable ophthalmic light exposure limits and professional guidelines.

Adverse Effects

Incorrectly adjusted brightness or prolonged direct viewing of the light source may cause temporary visual discomfort, glare or eye strain.
Inadequate cable management may create a trip or entanglement hazard in the clinical environment.
If the headband is overtightened or poorly adjusted, users may experience pressure marks, headache or discomfort during prolonged use.
Failure to clean and disinfect surfaces between patients can contribute to contamination or infection risks.
Very rare risk of burns or thermal discomfort if any component overheats due to misuse, obstruction of ventilation or technical fault; device should be switched off and inspected if abnormal heat is detected.

Storage Conditions

Store in a clean, dry indoor environment at standard room temperature when not in use.
Protect the headlight, headband and power pack from dust, moisture, direct sunlight and extreme temperatures.
Avoid mechanical shocks, dropping or placing heavy objects on top of the headlight or battery pack.
If storing for extended periods, ensure the mPack battery is stored in accordance with the manufacturer’s recommendations for lithium-based batteries (usually partially charged and periodically rechecked).
Keep the kit in its carrying case or original packaging where supplied, to protect optical and electronic components during transport and storage.
Ensure the device is disconnected from mains power when it is not in use or is in long-term storage.

Duration

Used intermittently or continuously for the duration of each examination or surgical procedure; the system is designed for repeated long-term clinical use over many years, limited primarily by LED life and battery/service intervals.