The SP1000 Range operating manual lists GMDN code 11963, NHS E Class codes FBU, FKR, IBB and commodity code 908400 for the SP1000 Range (covering SP1000 and SP1100).
The manual specifies that the SP1100 is a reusable medical device with LED light source, low Voltage operation and defined environmental and electrical specifications consistent with medical electrical equipment standards.
Daray corporate information states that the company operates ISO 9001 and ISO 13485 quality management systems for design and manufacture of medical lighting products.
The SP1000 Range operating manual lists GMDN code 11963, NHS E Class codes FBU, FKR, IBB and commodity code 908400 for the SP1000 Range (covering SP1000 and SP1100).
The manual specifies that the SP1100 is a reusable medical device with LED light source, low Voltage operation and defined environmental and electrical specifications consistent with medical electrical equipment standards.
Daray corporate information states that the company operates ISO 9001 and ISO 13485 quality management systems for design and manufacture of medical lighting products.
The product is a medical lighting device (surgical/examination headlight) and not a medicinal product; therefore, it does not have a medicine marketing authorisation or SmPC.
Description
The Daray SP1100 LED 10W Focusable Headlight is part of the Daray SP1000 Series of surgical and examination headlights. It is a lightweight, head-worn LED lighting system designed for use in all types of surgical procedures and examinations where a high demand for lighting and frequent mobility are required. The SP1100 uses a 10 W LED light source and high-quality optics to transform normal light into a clear, even and symmetrical lighting projection. It provides up to approximately 50,000 lux at 300 mm with a focusable light field from about 10 mm to 110 mm in diameter, and a colour temperature of around 5,000 K (±500 K) for near-daylight illumination and accurate viewing of tissue tones. The system comprises an adjustable headband with focus adjustment ring, external rechargeable battery pack with belt clip and variable intensity control, mains power supply/charger and a flight case that holds the headlight and accessories. From a full charge, the battery typically delivers around 5–40 hours of operation depending on the intensity setting, and the headlight can be used while it is being charged.
Bnefits
High-quality 10 W LED light source designed for use in all types of surgical procedures and high-demand examination settings
Variable intensity output and focusable beam allow precise adjustment of light level and light patch size to suit the procedure
Provides intense, shadow-free illumination with light intensity at 300 mm of approximately 50,000 lux for the SP1100 model
Near-daylight colour temperature of around 5,000 K (±500 K) supports accurate viewing of tissue tone with minimal colour distortion
Focusable light field at 300 mm from approximately 10 mm (narrow beam) to 110 mm (wide beam) for flexible use from fine work to broader field lighting
Rechargeable battery pack with belt clip provides cordless operation and can power the headlight for approximately 5–40 hours from a full charge, depending on intensity
Head-mounted design ensures the light follows the clinician’s line of sight, improving visibility and ergonomics during procedures
Extremely lightweight and easily adjusted headband allows comfortable use for long periods
Supplied with a robust flight case that holds the headlight, battery pack, power supply, power cable, sweatbands and accessories for safe storage and transport
Compatible with optional optical loupes available in a range of magnifications and focal lengths to allow magnified, illuminated viewing of intricate structures and to help reduce eye strain
The product is a medical lighting device (surgical/examination headlight) and not a medicinal product; therefore, it does not have a medicine marketing authorisation or SmPC.
LED surgical/examination headlight
Indications
Head-mounted illumination for all types of surgical procedures requiring a focused, high-intensity light source
Use in examination and diagnostic settings where high-quality mobile lighting is required (e.g. ENT, maxillofacial, dental, dermatology, aesthetic medicine, veterinary and similar clinical areas)
Situations demanding accurate colour rendition of tissues and a clear, even, symmetrical lighting projection
Procedural environments where higher lighting demand and frequent mobility make head-mounted LED lighting preferable to fixed luminaires
Composition
LED light source (10 W nominal output for SP1100) housed in a compact lamp head
Adjustable headband with top and rear adjustment knobs and replaceable sweatbands (two supplied)
Focus adjustment ring on the lamp head to provide a focusable light field at 300 mm (approx. 10–110 mm diameter)
External rechargeable battery pack (approx. 4.2 V DC, 1.2 A, 4400 mAh nominal) with belt clip, power indicator light and intensity control/power switch
Power supply unit rated for 110–240 V AC, 50/60 Hz with power cable and DC output to the battery pack
Flight case designed to hold the headlight, battery pack, charger/power supply, cables and supplied accessories
Optional optical loupes with frames (various magnifications and focal lengths) that can be attached and adjusted for pupillary distance (ordered separately)
Labelling including model identification (SP1100), serial numbers and regulatory/product codes as per the operating manual
Formulation
Medical LED headlight system comprising SP1100 10 W LED headlight, adjustable headband and external rechargeable battery pack
Light source: LED, 10 W (SP1100 model) with approximate colour temperature 5,000 K (±500 K)
Light intensity at 300 mm: SP1100 approximately 50,000 lux (focused beam)
Light field diameter at 300 mm: focusable from approximately 10 mm (narrow beam) to 110 mm (wide beam)
Battery run-time from full charge: SP1100 approximately 5–40 hours depending on light intensity setting
Average LED working life specified as greater than 25,000 hours
Input voltage (battery charger unit): approximately 110–240 V AC, 50/60 Hz; output to battery pack approximately 4.2 V DC, 1.2 A
Temperature rise on patient/user specified at approximately 2 °C under normal operation
Supplied with replacement battery pack and power supply part numbers for the SP1000 Series (battery pack CS6206; charger/power supply CS6207) as detailed in the operating manual
Packaging
Supplied in a smart, tough, lockable flight case designed to protect the headlight system during transport and storage
Standard package contents as per SP1000 Range operating manual typically include: SP1100 10 W LED headlight with adjustable headband and focus control ring, external rechargeable battery pack with belt clip, mains power supply (110–240 V AC) and power cable, two sweatbands and user documentation
Flight case holds the headlight, battery pack, charger/power supply and accessories in dedicated compartments to minimise damage and facilitate portability
Optional optical loupes and spare parts (replacement battery pack CS6206, replacement power supply CS6207) are available separately and are not included by default unless specified at order
Usage
Before use, perform a system check as described in the operating manual: inspect the device for mechanical damage, confirm that all functions work normally and ensure that the battery has sufficient charge; do not use the headlight on a patient if there is damage, abnormal function or suspected hidden safety risk.
Connect the headlight power cable to the battery pack.
Switch on the battery pack using the intensity/power switch; verify that the green power indicator LED on the battery pack illuminates to show that there is sufficient charge.
Place the headlight on the head and adjust the fit using the top and rear adjustment knobs on the headband until it is secure and comfortable.
Use the focus adjustment ring on the lamp head to set an appropriate light field size (approximately 10–110 mm diameter at 300 mm) for the intended procedure or examination.
Align the direction of the projected light with the user’s line of sight and secure the position using the locking mechanism as detailed in the manual.
Clip or secure the battery pack to the user’s clothing or belt using the integrated belt clip so that it is stable and does not impede movement.
Adjust the light intensity using the intensity control/power switch on the battery pack to suit clinical requirements and user comfort.
For recharging, connect the charging cable from the power supply to the battery pack; the green charge indicator LED will illuminate during charging and will extinguish when fully charged, at which point the charger can be disconnected.
From a full charge, the SP1100 battery typically provides approximately 5–40 hours of use depending on the intensity setting; the headlight may also be used while charging as permitted by the manual.
For routine cleaning, power off the device and disconnect the headlight from the battery pack before cleaning; wipe external surfaces gently with a clean, soft cloth, sponge or cotton swab dampened with a suitable, non-erosive cleaning solution (e.g. diluted soap solution, 70% isopropanol or ethanol, diluted ammonia water, 3% hydrogen peroxide or appropriately diluted sodium hypochlorite).
Avoid allowing fluids to enter the casing, switches or openings; do not submerge the device in water or cleaning solutions and do not spray liquids directly onto it; after cleaning, wipe off any remaining solution with a dry cloth and allow the device to air-dry away from intense sunlight or high temperatures.
Disinfection, if required, should be carried out using compatible alcohol-based or aldehyde-based agents as recommended in the manual, and only when necessary in accordance with hospital infection-control procedures; high-pressure or high-temperature sterilisation, ethylene oxide and undiluted formaldehyde are specifically not recommended.
Observe all safety precautions in the manual, including not shining the light directly into the eyes of any person or animal, not using the device if the power cable is damaged or if exposed wiring is visible, and handling the light and optical surfaces carefully to avoid damage.
Contraindications
Not publicly listed (no formal clinical contraindications are specified in the SP1000 Range operating manual; use is governed by general medical electrical device safety guidance and the clinician’s professional judgement).
Adverse Effects
The operating manual warns not to shine the headlight beam directly into the eyes of any person or animal, as this could potentially cause serious retinal damage.
Electrical safety risks may arise if the power cable or other electrical components are damaged or if exposed wiring is visible; in such cases the device must not be used.
Improper cleaning or disinfection (for example, submerging the device in liquid, allowing fluids to enter the casing or using strong or incompatible solvents such as acetone) may damage the device and create safety hazards.
Excessive headband tension or poor adjustment could cause user discomfort or headache during prolonged wear, although this is not listed as a formal adverse effect in the manual.
No specific clinical adverse effects on patients are documented in the operating manual beyond standard cautions relating to bright light exposure and general electrical medical device safety.
Storage Conditions
Transport and storage environmental conditions specified in the operating manual: temperature approximately –40 °C to +55 °C, relative humidity up to about 80% and atmospheric pressure range approximately 50–106 kPa.
The headlight and battery pack should be kept clean, dry and protected from excessive moisture, liquids, dust and mechanical shock during storage and transport.
The device is not waterproof; it must not be submerged or stored where liquids may enter the casing, connectors or switches.
The device should be stored away from intense sunlight and high temperatures; after cleaning, it should be allowed to air-dry rather than being dried using strong heat sources.
Duration
The Daray SP1100 headlight is intended for continuous use during medical examinations and surgical procedures. From a full battery charge, typical operating time is specified as approximately 5\u201340 hours depending on light intensity setting, after which the battery must be recharged. There is no fixed clinical treatment course duration; usage is determined by the length and frequency of procedures and examinations.
Onset
Illumination is effectively immediate when the battery pack is powered on and the light intensity is set; the manufacturer does not state a quantified onset time in seconds or minutes.
