1.Principle: Breastlight is based on the transillumination process. It is essentially a battery operated red light source which is used to illuminate the breast and allow the user to examine their own breasts in a darkened environment. This product is intended to be a home use, relatively low cost, simple hand held device to assist women in being breast aware.
2.Light wavelength & absorption: It shines bright red light through the breast tissue and is very effective at illuminating the inside of the breast.The red light at ~620nm is transmitted relatively well by the breast tissue and is strongly absorbed by Hemoglobin in the blood. When used in a dark environment the user can clearly view some of the internal structure of their breast including their own blood vessels. If there is a breast abnormality such as a blood filled cyst or breast cancer the device can allow the user to see a darker shadow associated with the absorption of the red light of the blood associated with the abnormality. The product is intended to be used after a woman has performed her normal breast self examination as a further check of the breast using a visual means as well as by tactile means. The device is not intended to be used as a diagnostic tool for breast self-examination but as an aid to women to be used to support the breast self-examination process.
The product comprises an array of high power red LED’s mounted on a circuit board. As the LED’s give off heat as well as light this board is thermally bonded to a heat sink. The LED’s are powered by an internal rechargeable NiMH battery. The battery is charged though a separate external transformer. To allow women to use the product if the batteries are flat the device also allows operation while plugged into the transformer. A micro controller provides the control of the battery, heat and the LED output. Safety features are built into the device to prevent shock, overheating etc. These components are housed in a suitable ergonomically designed injection molded enclosure. The unit is sold with power supply, Instruction for Use (IFU), instructional DVD, lubricant sample and packaging.
Breastlight complete box = 740 grams
Volumetric weight =           600 gram
Breastlight unit only =        300 gram
Power Supply:
Breastlight has dual power supply options
1.5V, 4 x 1500 mAh AA NiMH rechargeable battery.
Low discharge NiMH battery has been used in Breastlight. Battery is capable of holding 500 full charges.Charging time from fully discharged to fully charge is about four hours. There is no provision for forced ventilation required to reduce this time.
2.Charger -DC power supply,9V DC with Minimum 0.6 Amps load
Frequency range: 50-60Hz, Input voltage range 110 – 240V.
The device can be used while the mains lead is plugged in for recharging. Recharging is temporarily halted while the unit is powered on. Jack should resist accidental removal while device is being used. The DC jack socket and main PCB are to be protected from damage resulting from a sideways pull on the power cable. A 2m cable length is required to ensure that a standing user has unimpeded use of the device when plugged into a low level socket.
Peak output        Charger            Rechargeable Battery
Tension (V)          9 volts               4.8 volts
Current (A)          600 mAmps       1500 mAh
Power (W)           5.4 watts           5.4 watts
Electric Requirement    110 – 240 volts, 50 / 60 MHZ Frequency
Maintenance: Breastlight is designed to be maintenance free.
Thermal Management:
Little heat is produced due to 3 LED’s so being on safer side heat sink is installed in unit for thermal management. Ideally the breast tissue should feel no heat sensation at all, i.e. temperature of housing stabilizes at approximately 40C. Maximum temperature of external surface of housing before thermal cut-out is triggered is 45C.
Components & materials: 1.Upper Housing moulding: PC-ABS injection moulding. 2.Lower Housing moulding:PC-ABS injection moulding.3. Window: Optically clear PC injection mouldings.4.User interface buttons-On/Off and Intensity Adjust increase/decrease:5.2 shot PC-ABS/thermoplastic rubber injection moulding.6.UI Bezel: PC-ABS injection moulding,Screw cover:PC-ABS injection moulding.7.Light Guide/Capacitive switch sensing surface: Metal pressing.8.Heat sink: Aluminum alloy die casting.9.Main PCB including board mounted DC power jack.10.LCD display with backlight.11.LED PCB with 3x 3W Luxeon power LEDs,5V,1500 mAh NiMH rechargeable battery, Conductive layer between Power LED and Heat Sink.12.DC jack socket seal:Thermoplastic rubber injection moulding
To provide a low friction skin to device interface, to reduce rubbing–Lubricant (10ml tube) has  been included complimentary to be used which has the following features 1. Quickly warmed to body temperature, 2.Does not interfere with the operation or charging of the device or present any kind of electrical hazard, 3.Can be contained within the area where skin contact could occur, 4.Easily removed from the body using wipes or absorbed by the skin, 5.Dispensed in a measured volume to avoid waste, 6.Pleasing smell
Only lubricant and battery are the consumable parts of the breastlight.
Quality Tests:
Breastlight passes through a series of following tests–temperature shock test,shock test, vibration test, drop test, sand & dust test, altitude test,salt spray test,
The Breastlight device complies with the following standards:-
Standard Title
EN60601-1:2006 Medical electrical equipment –Part 1.1 General requirements for basic safety and essential performance.
BS EN ISO 14971:2009 Medical devices- Application of risk management to medical devices.
BS EN 1041:2008 Information supplied by the manufacturer with medical devices.
EN 980:2008 Graphical symbols for use in the labeling of medical devices.
EN ISO 10993-1:2003 Biological evaluation of medical devices – Part 1: Evaluation and testing (ISO 10993-1:2003)
ISO 15223-1:2007 Medical Devices-Medical Devices – Symbols to be used with Medical Device Labels, labeling and Information Supplied– Part 1 General Requirements
The product should last with ‘typical use’ for at least 5 years under a normal duty cycle.The limitation is likely to be set by the life of the sealed-in rechargeable batteries. A normal duty cycle is defined thus: fortnightly use for 10 minutes LED ON duration (at max intensity) with a full recharge in-between each test
This product is recognized as a skin contact only device. As a result,the plastics in use shall conform to the requirements of medical grade plastics and comply with the relevant parts of EN ISO 10993-1:2003 and shall be Non cytotoxic 10993-5, non sensitization EN ISO 10993-10:2002 and haemocompatible 10993-4:2002.
Risk Analysis:
Risk analysis for the system has been performed according to BS EN ISO14971:2007 Medical Devices– Application of Risk Management to Medical Devices.
Representative Product Labeling and Instructions for Use Product labeling:

Is prepared in accordance with the Essential Requirements laid down in Annex I of Council Directive 93/42/EEC. Packaging and labeling documentation is presented as Section 6.0 of this Technical File.
Operating and storage temperature and humidity:
Climatic category (IEC 60068-1) 40 / 50 / 56 for bipolar operation and storage
25 / 50 / 56 for normal operation.
cold test at –40 /-2°C (bipolar operation and storage) or –25 /-2°C (normal operation), where humidity is not controlled
dry heat test at 50 /-2°C where the relative humidity may not exceed 50 % but is not specifically controlled
damp heat test at 40 /-2°C at 93 /-2% humidity for 56 days.
Breastlight operates normally in all the above mentioned conditions.
General Cleaning:
Protects the internal components from ingress of dust, typical moisture from a cleaning/disinfecting wipe and any lubricants used, Easy to clean. Dirt traps minimized, Compatible with chemicals used in cleaning/disinfecting wipe and any ubricants used, provides a captive (retained by housing) rubber bung for sealing the DC jack socket when device is being cleaned or lubricant is being used
The device is used in a domestic environment.The testing will be performed where
a dark space can be created, typically a bathroom or bedroom. The device will
typically be stored in a cupboard or drawer.
The device is to be designed for women users aged 25 to 75.
User interface:Intuitive user interface,even in fully dark environment.
LED intensity can be adjusted while device is illuminating breast with the same
hand that is being used to hold the device.
Appearance:Expreses the following attributes:
1year exchangeable-Warranty will not apply if device is damaged
through misuse.
Legal Status:
Registered in MHRA as Class1medical device in UK & Europe.
Information Booklet Version:
Version of Manual – Latest EN1.1
Breastlight Software:
Breastlight is using version 1.1 firmware.
Breastlight Technical Code:
Breastlight has technical code BL801.



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