SAFETY PRECAUTIONS¶
Warnings and Cautions¶
Read and practice the following general warnings and cautions when you use the CAM1.
General Warnings and Cautions¶
Do not attempt to operate the CAM1 until you have read and thoroughly understood the directions and warnings in this user manual.
Warnings¶
A warning statement in this manual identifies a condition or practice, which if not discontinued or immediately, could lead to injury, illness, or death.
WARNING |
To avoid exposure to biohazardous material, adhere to standard protection from blood-borne pathogen exposure procedures, including the following: |
WARNING |
Risk of explosion. Do not use the in the presence of flammable liquids or gases, including flammable anaesthetics. |
WARNING |
Medical professionals should never make a diagnosis based solely on the images. |
WARNING |
High energy concentrated light. Do not look directly into the light source. |
WARNING |
This product has no user serviceable or replaceable parts except for the lens. Repairs made by anyone other than KK Research Technology Limited certified individuals will void the product warranty. |
WARNING |
The USB port output connector must ONLY be connected to a battery powered notebook computer with no other wired connections to any other device. The laptop computer must only be ever powered form a mains supply using a IEC 60601-1 certified power supply when used with the . |
Cautions¶
A caution statement in this manual identifies a condition or practice, which if not discontinued or immediately, could lead to equipment failure, equipment damage, or data loss.
CAUTION |
In order to obtain optimum performance and to ensure patient safety, thoroughly read this document. |
CAUTION |
Never use if you notice any signs of damage to any components of the system. |
CAUTION |
Do not attempt to disinfect the with glutaraldehyde products, ethelyne oxide gas, steam, or any other liquid or gas disinfectant. |
CAUTION |
This product complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other devices. |
Laser Safety¶
Caution- use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
The CAM1 contains a low power infra-red semiconductor laser diode.
The maximum accessible output power from the CAM1 is 1.5mW.
The output wavelength is nominally 780 nm.
The laser beam is focused to a spot about 5mm in front of the CAM1 L300 objective. The L300 objective has a numerical aperture of 0.14 Beam divergence from the focal point is about 16 degrees.
The CAM1 is supplied with the following labels ( black on yellow background) fixed on one side:
In normal use the CAM1 is positioned such that it is impossible to view the laser beam directly. For other uses the user should take precautions to prevent continuous viewing of the laser beam.
Although the CAM1 satisfies the Maximum Permissible Exposure levels (MPE) for skin exposure, the user should be aware that the power density is very high at the focal point.
The main biological hazard from infra red radiation is considered to be due to heating. With the CAM1 in normal use, the total power is low and tissue mass large, skin tissue and red blood cell absorption at 780nm is low, and the power at the focal point will be much reduced in normal use due to scattering within the tissue. The CAM1 uses continuous wave (cw) radiation so there are no thermoacoustic transients. Latent or cumulative [photochemical] effects of laser radiation have not been found prevalent.
Certification¶
This product meets the provisions of Council Directive 93/42/EEC
(Medical Devices Directive) Annex VII. It complies with standards:
EN 60601-1:2006 Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
EN 60825-1:2007 Safety of laser products. CLASS 1.
