Chapter 1 Safety Warnings and Cautions
1-5
1.2
Safety Caution
Read and follow all safety cautions thoroughly before using the product.
Be sure to observe the cautions described here, since it is regarding about the safety.
1.2.1 Caution Based on Ordinance
Laser unit specification of the REGIUS MODEL 110
REGIUS MODEL 110 is laser class I product.
Notation According to Pharmaceutical Law
Following are text from "Caution regarding usage (safety and prevent danger) of the medical electric
equipment", required to attach by Notification Number 495 of Pharmaceutical Affairs Bureau, Ministry of
Health and Welfare (June 1, 1972). Read this caution closely and operate properly.
Caution regarding usage (safety and prevent danger) of the medical electric equipment
1. Equipment should only be operated by skilled operator.
2. Note following items when installing the equipment.
(1) Install in position where no water spills.
(2) Install in location where air pressure, temperature, ventilation, sun light, dust, salt, sulfur, etc.,
does not affect the equipment.
(3) Note the stability such as inclination, vibration, shock (including transport), etc.
(4) Do not install where the chemical is stored or where the gas is generated.
(5) Note the frequency and allowable current (or power consumption) of the power supply.
(6) Confirm the status (abandoned status, polarity, etc.) of the battery power supply.
(7) Connect to the ground correctly.
3. Note following items before using the equipment.
(1) Confirm that the equipment works properly by checking the contact of the switches, polarity
dial setting, meters, etc.
(2) Confirm that the ground is connected safely.
(3) Confirm that all the cords are connected properly and safely.
(4) Be careful that simultaneous use of the equipment might lead to wrong diagnostic or cause
danger.
(5) Confirm the battery power supply.
4. Note following items while operating the equipment.
(1) Be cautious that you do not go over the necessary time or amount needed for diagnostic or
treatment.
(2) Always monitor that there is no problem with the equipment and patient.
(3) Perform appropriate measure, such as stopping the equipment safely to patient, when a
problem is found with the equipment or patient.
(4) Be cautious that patient should not touch the equipment carelessly.
Caution regarding laser regulation
To prevent danger, do not remove the external covers or touch inside the equipment
except the service engineer with official training.
Item
Specification
Class
IIIb
Medium
Semiconductor laser
Wavelength
660 nm
Maximum output
130 mW (CW)
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