Breastlight: History, Operation, and Advantages

2. Index: History of Breast Transillumination / Breastlight Operation of the Breastlight – standard Advantages and recommended uses of the Breastlight Tips for achieving the best results. Recommendations for use of Lubricant Breastlight performance and limitations. Regulatory status Engineering Mode / Service / battery replacement Summary of clinical evidence / clinical trials Future and potential products and applications. Questions / other topics

3. History of the Breastlight: • Breast Cancer first observed using transillumination 1929 – Max Cutler • Red light transmitted well by breast tissue, red light absorbed by blood. • Various attempts to use visible and IR breast transillumination at alternative diagnostic equipment to X-Ray Mammography – 1970-1990. • Sensitivity in range 60-90% so not an alternative to X-ray mammography. • Dr Watmough developed home use version to help BSE. • High power LED’s allowed miniturisation / cost reduction. • PWB created between Polaroid and WideBlue (Design Co) • in 2007 to develop Breastlight and take product to market. • Breastlight Launched in July 2008 – Class 1 Medical device • – aid to Breast Self Examination / Breast Awareness.

4. Design Features of the Breastlight. • Intuitive design – no similar product exists but users immediately understand it. • Symmetrical – Can be used with Right and Left handed people. • Can be held in may ways. • Suitable for checking all areas of the breast including next to armpit. • Simple operation – two button. • Feminine design / feminine colours. • 4 brightness settings for ALL breast sizes / types. • Mains or internal battery power. • Feminine Instructions for use (IFU) • IFU, DVD and Retail sleeve can be customised for any language. • Standard internal box.

5. Operation of the Breastlight – standard operation. • Displays number of days since last used. • Charge Breastlight • Alternative mains power. • Dark Room • Capacitive switch operation resets number of days since last used. • Anti Dazzle • Adjust Brightness to suit – 4 levels • Look Down or in mirror. • Move Breastlight about ALL breast • Recommend use of lubricant • Check both breasts • Wipe off excess lubricant • Charge after use. • Use monthly / check number of days since last used.

6. Operation of the Breastlight – standard operation.

7. Advantages and Recommended Uses of the Breastlight • The Breastlight is of particular value to: • Women who are unsure about how to carry out a monthly breast self examination • Women who particularly worry about Breast Cancer • Women who have a family history of Breast disease • Women with naturally fibrous / lumpy breasts – may have given up on self checking due to number of lumps. • Women of all ages • Women who are reluctant to visit their doctor – cost or cultural reasons – breastlight may encourage them to visit. • Monthly self heck – reinforced by No of Days since last used. • Particularly useful in conjunction with regular medical checks.

8. Tips for achieving the best results • Use the Breastlight after carrying out normal Breast Awareness / Breast Self Examination routine. • Very Dark room • Avoid setting Breastlight too bright / too dull for age and size of breasts. • Use in front of a mirror • Perhaps check with partner / daughter if unsure • Use a lubricant • Use regularly – recommend about once per month. • Get used to the shape of your blood vessels. • Look for changes. • If in doubt seek a medical opinion. • Remember limitations of Breastlight – not an alternative to mammography.

9. Breastlight Lubricant • Breast Self Examination is easier with lubricant. • Off the shelf lubricants are effective but often messy – difficult to carry out examination with lubricant on your hands. • Some glycerine based lubricants leave sticky residue. • Oil based lubricants are not compatible with Breastlight plastic materials. • Breastlight Lubricant is specially formulated for Breast Transillumination. • Roll on lubricant only dispenses fluid to dry skin – only applied where required – this minimises mess. • Small sample provided with Breastlight to get a woman started. • Aim is to drive sales of Breastlight lubricant.

10. Breastlight performance and limitations • Users are encouraged to look for changes – easier with regular use. • Light transmits through breast tissue and is absorbed by the presence of blood. • Most women will see only veins / arteries / blood vessels. • If there is other blood present then there will be light absorption which the user will see as a shadow. • Moving the Breastlight around the surface will allow a good view of any feature. • Shadows have been seen for the angiogenesis associated with cancer, blood filled cysts, scar tissue, bruising, post biopsy blood relocation. • Detection of cancers will depend on a number of factors including size and location of cancer. • Cancers have been detected as small a 7mm. The limit for palpation is 10-15mm. • Not suitable for lactating women • Can be used by women with breast implants but cannot be used to visualise implants (implants transmit light they do not absorb light).

11. Breastlight performance and limitations (continued) • Particularly useful for use by women with fibrous / lumpy breasts. • Fibrous tissue is non vascular so does not absorb light. • Suitable for use with dark (African) skin. • Because not cancers always detected with the Breastlight (depending on size and location) we can make no claim the breast cancer, breast lumps or other breast disease will be found when using Breastlight.

12. Regulatory Requirements and Classification: Intended Purpose: The Breastlight is intended to be used as an aid to Breast Self Examination / Breast Awareness. The classification of the Breastlight according to Annex IX of the European Medical Device Directive 93/42/EEC is: Class 1 according to rule 12. • As a Class 1 medical device: • CE marked under declaration of conformity. • Notification sent to Competent Authority / No requirement for notified body. • Procedures required for vigilance, post market surveillance, recalls. • Compliance with essential standards: • EN ISO 14971 – RiskAssessment • ISO 10993 – Bio Compatibility • EN 980:2008 / EN 1041:2008 – Labelling / IFU • EN60601 – Electrical – EMC, ESD, Low Voltage Directive • EN60825 – 1 – LED Class 1 product. • Contract manufactured under ISO 9000.

13. Implications of Regulatory Status: • Breastlight is an aid to breast self examination / breast awareness. • No claim can be made that Breastlight is effective in the diagnosis of Breast Cancer or other Breast disease. • Distributor in Canada made unauthorised change to intended purpose. • Health Canada reclassified the Breastlight as a Class 2 device and ordered a product recall. • Due to the potential for misuse of the Breastlight we state that: • Breastlight is not a substitute for regular scheduled mammogrpahy. • Breastlight may highlight something that subsequently turns out to be benign. • Breastlight is not capable of detecting all sizes, types or locations of breast abnormalities. • If in doubt seek the opinion of a medical professional. • Any local marketing literature should be approved by PWB Health.

14. Engineering Mode: • Temperature of Breastlight • Battery Voltage • Firmware version • Useful for diagnosing problems: • Potential overheating – perhaps unit dropped. • Potential battery failure – may only charge to 4.2V if one cell fails. • To Access Engineering mode: • Press and hold top button • Press and hold bottom button • Release top button • Release bottom button • -> Circle flashes • -> Toggle through No days / Temp (deg C) / Voltage (x0.1V) / FW version.

15. Opening Breastlight Serial No Press plastic wedge into space (not metal) Remove 2 screws star screwdriver. Remove back cover – keep chassis and top cover together.

16. Removal and replacement of battery Pull battery out of main board connector Prise battery off chassis – retained with foam adhesive.

17. Summary of clinical evidence / clinical trials • Three main trials with Breastlight: • Womans Institute Trials – October 2008 • UK NHS clinical trials – December 2009 • Edinburgh Napier University – October 2010 • Main Findings: • Women Institute Trials • – Breastlight encourages women to check more frequently. • - Breastlight improves Women confidence when self checking their breasts • 2. UK Clinical Trials • - Breastlight results compare favourably to final diagnosis using mammography, cytology / histology • - Sensitivity 65%, Specificity 85% • - Low level of false positives 3.2% • 3. Edinburgh Napier University • - Increase in confidence in 50% women, 44% increase in frequency in carrying out self examination.

18. Future and Potential products and applications. • Patent also covers testicular cancer. • - Doctors check for testicular cancer with a white light torch! • Future Medical Breastlight • Brighter LED’s to allow daytime use, greater range of brightness's, medical grade power supply, new firmware / display. • Potential for combination of Breastlight and Mammography may have advantages – research required. • Potential for Developing countries to use Breastlight where no alternatives exist.