HEINE ML4 HeadLight Kit LED mPack Plus Plug In Transformer
HEINE
LightingMedical Headlight / Surgical Headlight
Certifications
- 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.
Onset
Full-intensity illumination is available immediately when the headlight is powered on and brightness is set; no warm-up time is required.
