PreCise 002-00177, Руководство пользователя

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• Standard operating procedures to regulate the work
environment in order to protect the patient and staff from
laser hazards.
The safe use of a laser is the responsibility of the LSO, who can
be a full or part-time employee or the laser operator. It is their
responsibility to train the staff, maintain records concerning
training and the laser’s performance, perform safety checks,
and prepare the laser for use on a daily basis. The LSO must
keep records of any incidents that relate to the failure of the
laser or any adverse effects related to laser treatment and
report such incidents as proscribed by law. The laser safety
officer assures that a medical follow-up has been sought or has
occurred following any adverse incident during treatment. The
LSO is responsible for the training of all office personnel who
are involved with the laser preparation and use.
Daily checks of the facility and equipment are also the LSO’s
responsibility. The LSO should test fire the laser each day
prior to beginning each treatment procedure. The LSO should
insure that the operator and staff attend laser courses taught
by qualified laser educators. Ongoing reviews of laser safety
procedures should be a part of normal office routine.
5.2.2. Operatory Signage
Each treatment area should have a “Laser In Use” warning sign
posted outside the entrance to the treatment area. This signage
serves to warn people to not enter the treatment area without
proper safety eyewear when the laser is in use. See Figure 5.4.
5.2.3. Protective Eyewear and Clothing
While using the Precise SHP laser, doctors, auxiliary staff,
patients, and anyone attending them in the operatory must
wear the appropriate safety eyewear that has been designed
for use with the 810 nm wavelength. We strongly recommend
you use the glasses provided with the Precise SHP system or
obtained from CAO Group or one of its authorized dealers.
Regardless, ensure that protective eyewear that is used is rated
for 810nm laser energy with an Optical Density (OD) of 4 or
higher at this wavelength.
Never point the laser tip directly at the eyes, or the face or
skin unless this is the target tissue, of anyone while emitting
laser energy. The aiming beam is capable of causing eye
damage. Avoid pointing the laser at clothing or organic matter
in general. Common clothing should be acceptable at blocking
laser energy, but laser energy directed at dark colored clothing
or materials at short distances and/or at high settings may
cause smoldering or ignition of the clothing or material.
5.2.4. Plume Evacuation
Use high volume evacuation suction during procedures to
remove laser smoke or ‘plume’ debris. Use masks suitable for
viral filtration.
CAUTION – Laser plume may contain viable tissue
particulates.
5.2.5. Sharps Disposal
Used handpiece tips must be discarded in an appropriate
sharps container. Any fiber fragments that may be generated
should also be placed in a sharps container. All sponges used
for cleanup of lasers and fibers should be disposed of in a bag
for contaminated soft products.
5.2.6. Laser Security
To prevent unauthorized access and use of the Precise SHP,
we recommend that the Display be locked using the Lock Key
at bottom right on the screen. This should be done anytime
the operator is away from the Display Module or from the
operatory. The Passcode should be changed when the device
is first received and set up. The LSO should record the code in
a secure location in case it is forgotten. It is also recommended
that you change the code on a regular basis.
5.2.7. Nominal Occular Hazard Distance (NOHD)
The NOHD is the distance beyond which the exposure, during
normal operation, is not to exceed the appropriate Maximum
Permissible Exposure (MPE). The NOHD for persons wearing
safety glasses is shown in Table 1 below. The Nominal Hazard
Zone (NHZ) is the area around the laser source where the
exposure levels exceed the MPE (which is the highest level of
laser radiation to which a person may be exposed without
hazardous effects or adverse biological changes in the eyes or
skin). The outer limit of the NHZ is the NOHD. Eye Protection
within the NHZ is mandatory. (See Table 5.1 below)
*Assumptions: Maximum Laser Power = 3 Watts, Direct Viewing
Angle = 0°; Reflectance Viewing Angle = 20°; Reflectance
Coefficient of Tissue = 0.001, Exposure Duration = 10 seconds
Table 5.1. Nominal Ocular Hazard Distance values for different scenarios.
Source of Laser
Radiation
MPE (mW/cm
2
) Divergence Angle
(degrees)
NOHD
No Eyewear (in/cm) With eyewear, OD=4
(in/cm)
Handpiece Tip 1.67 13 83/211 0.83/2.11
Reflectance from Skin 1.67 13 0.023/0.06 0.00023/0.0006