SIGMOLUX is delivered as a ready to go complete system. No assembly is required.
SIGMOLUX is a complete sigmoidoscope system designed to assist in reducing procedure times. During insertion the obturator (which includes the patented 'CLEAR VIEW' system which ensures that the light guide cannot become occluded during insertion) remains in place. Once the SIGMOLUX is positioned the obturator is simply pulled smoothly out of the barrel. Light is transmitted to the end of the barrel via an extended light guide. A latched air tight viewing lens closes the barrel allowing the system to be pressurised using the included inflation bulb. A built in air reservoir supports the inflation pressure. At completion of the procedure pressure can be reduced using the release valve on the inflation bulb before releasing the lens latch. The entire system can then be thrown away.
We worked to ensure that we didn’t change work practices. Thus our range of products doesn’t ask you to make procedural changes, but simplifies current practice. On removal from the individual package there is no assembly required, all of the necessary feature set is included as standard, with the product in its entirety being thrown away at the end of the procedure. SIGMOLUX is supplied complete, including inflation bulb and reservoir, with a lens to aid site observation.
One of the substantial challenges is to ensure that both the sigmoidoscope and proctoscopes in the LUX range deliver 100% of the light available from the light guide to the examination site. For such product there is always the risk that the distal end on the light guide may become occluded by faecal matter.
SIGMOLUX employs our patented ‘CLEAR VIEW’ system which ensures that no occlusion of the light guide occurs. The system consists of a flexible shutter, attached to the obturator which while the product is being inserted closes the gap between the scope barrel and the obturator body. Once the scope is inserted and as the obturator is removed, the patented shutter automatically lifts over the light guide ensuring a clear view of the examination site.
One of the challenges for visualisation of the site is ensuring a clear, well illuminated field of vision. The majority of the products we reviewed before designing the ‘LUX’ range either lacked any illumination or relied on external power supplies connected to bright light sources at the proximal end of the device. While such sources produce strong illumination at the user end, the actual light delivery can be much reduced before it makes it to the examination site. Worse still, stray light from some sources further interfered with a clear view of the site. Other devices offered no light source – possibly a free penlight which was intended to be used repeatedly case after case.
We found that traditional light sources can be the cause of much frustration in use, wires for power supplies can be inconvenient, sometime dragging on the device, also the light sources and cables need to be cleaned and disinfected before reuse to avoid the risk of cross contamination, taking costly time, and generally requiring investment in a number of light sources/cable sets to minimise downtime but adding further capital costs. Penlights provide less illumination, and require intensive cleaning and disinfection to avoid cross contamination hazards.
All of our products include a self-contained light source and delivery system. Light is generated in the device handle and then transmitted up a light guide to ensure maximum delivery at the site of interest. The light source is an intense LED guaranteed to maintain maximum brightness for 30 minutes – far longer than the procedures the products are designed for. There are no cross contamination issues, the entire product, including the light source can be safely disposed of in the clinical waste. This also removes the need to duplicate costly light sets, and the need to clean and disinfect wires and light sources between cases.
We're often asked whether 'everything' can be thrown away, with a level of disbelief that it's OK to throw anything with batteries inside away as waste. The light pack in our product contains batteries to power the LED, however these batteries are alkaline only – they don’t contain any of the heavy metals that you’ll find in most batteries in your local store. As clinical waste the applicable directive allows these batteries to be incinerated along with other contaminated waste – thus the entire product is indeed fully disposable.
We've also been asked about potential fire risk from shorting batteries. Part of the design brief included short circuiting the battery packs and monitoring the effect. Short circuiting fully charged cells only increased the battery case temperature from ambient (25o C) to 44o C. We also ran a series of scenarios with conductive liquids (as you might find in a waste bag) without seeing any significant temperature increase.
Irrespective of the above, and based on local waste disposal policies you may not wish to dispose of batteries in the waste stream. The light pack can be separated from our products manually if required.