Summus Medical Laser KP User Manual
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Instructions Before Use
Thank you for using the Platinum Laser System！
When receiving this product, please check the integrity of the packaging.
Refer to the packing list and check the product components and their
quantity. If there are any packing damage, equipment damage or
component missing, please contact our sales personnel or dealer for
replacement.
In order to serve you better, please confirm the packaging in good
condition and check the product set, fill out the product receipt, the user
file form and training records, and return to the company promptly.
It is recommended that users receive train before use, and read the
instructions, and have the relevant security measures to avoid the
damage on the human body and equipment that caused by the
possible harmful laser radiation in the course of use.
The company will not be liable for any personal injury or damage to
equipment caused by the failure to follow instructions in the course of
use.
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Table of Contents
1 Introductions
2 Indications
3 Contraindications
4 People with caution
5 Adverse Reactions
6 Specifications
7 Safety Warnings
8 Installation
9 The appearance of the medical device
10 Operation Guide
11 Reminding Function Description
12 Maintenance
13 The Waste Dispose
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14 Product Identification And Packing Instructions
15 Electromagnetic Compatibility
16 FCC Statement
17 Services
18 Contact information
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1 Introductions
The Platinum Laser System is a therapeutic laser product for relieving mild muscle
pain and joint pain.The product uses intelligent human-computer interaction system,
which is committed to clinicians and patients to bring a safe and effective treatment
experience.
1.1 Model / Specifications and Divide Instructions
P4
1.2 Device Description
The Platinum Laser System is a Class IV laser product that uses GaAlAs
semiconductor lasers as energy sources to deliver laser energy to the treatment area by
an optical path transmission system. The optical transmission system is composed of a
flexible fiber connected to the laser source and handle switch, SAM905 coupler.
Clinicians set reasonable treatment parameters according to the patient's condition and
treatment, click the hand-held switch to start treatment.
Platinum Laser System has the following characteristics in the alleviation and
treatment of pain:
To provide a non-invasive treatment for patients with tissue pain, muscle strain
using laser irradiation.
With a stronger tissue penetration, 980nm diode laser can be more in-depth
role in the patient's tissue, significantly alleviate and improve local pain,
muscle strain and other symptoms.
There are continuous output mode and pulse output mode. With continuous
mode, the maximum output power is 24W which can provide doctors a variety
of effective treatment options.
With intelligent human-computer interaction system and the internal tutorial
video screen, the interface is more clear and the operation is more simple to
facilitate medical operations.
Provide a variety of security reminding function, to facilitate the safe and
effective use of this product.
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2 Indications
The Platinum Laser System as laser devices for medical application intended to
alleviate musculoskeletal pain, osteoarticular diseases and laser acupuncture.
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3 Contraindications
People with the following symptoms are disabled:
Melanoma, precancerous lesions
Pregnancy response of the crowd
Patients with acute hemorrhagic disease
Thyroid disease
Cutaneous tuberculosis
Active bleeding
Cardiopulmonary and renal failure
Pre - stroke symptoms
Acute inflammation associated with sepsis symptoms
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4 People with caution
Light sensitive populations
Patients with local or major anesthesia, heart disease, pulmonary disease,
hemorrhagic disorder, sleep apnea, immunocompromised patients
Do not accept laser treatment psychologically, do not meet the doctor's
treatment
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5 Adverse Reactions
In the course of treatment, doctors should pay attention to the treatment of patients
with the treatment site and treatment of skin conditions, adjust the corresponding
parameters or move the handpiece to adjust the energy convergence according to
treatment.
In the course of treatment, due to laser irradiation tissue, the treatment site of
the blood circulation will accelerate, there may be skin redness phenomenon.
In conventional treatment, reddening of the skin is normal reaction.
In the course of treatment, when laser irradiation site appears hot phenomenon,
appropriately move the laser treatment handpiece away from the treatment site
to reduce the energy convergence; or by setting the treatment parameters to
reduce the laser output power.
In the course of treatment, treatment should be immediately stopped and
thermal burns treatment must be done when the treatment site of skin burns,
blisters ,etc.
WARNING: The treatment parameters should be set according to the patient's
condition and clinical diagnosis. And in the course of use, make the appropriate
protective measures, operating the device safely and effectively in strict
accordance with the contents of the instructions. Otherwise, injury or damage
to persons or device may be caused.
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6 Specifications
Model
P4
Laser Classification
Class 4
Laser type
GaAlAs
Operation mode
CW/Pulsed
Wavelength(Working)
650±20nm,810±10nm,915±10nm,980±10 nm
Max Output power
24±2.4W
Wavelength(Indication)
650±20 nm
Max Indication power
＜2mW
Uncertainty for output power
≤±10%
Magnitudes of the cumulative
measurement uncertainty
≤±20%
Expected increase in the measured
quantities
≤±10%
Pulse frequency
0-20000Hz
Transmission system
200μm,400μm,600μm
Timer
0-3600s
Adapter input parameters
100-240VAC,50/60Hz
Main Unit input parameters
19VDC，5.8A
Battery capacity
3350mAh
Cooling Method
Air cooling（Heat pipe with coolant
）
Weight
≤3KG NW
Dimensions
300 220 200 mm
Date of manufacture
See product nameplate
Validity Period
5 years
Divergence Angle
25°
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7 Safety Warnings
Platinum Laser System is a Class 4 laser product. During use and maintenance, do not
look into the laser or direct beam to avoid irreversible damage to the eyes. For this
reason, some safety precautions must be observed when using this product as follows.
Otherwise, it may cause personal injury or damage to equipment.
7.1 Requirements to the Room
7.1.1Requirements to the entrance
Platinum Laser System is a Class 4 laser product. Each entrance door has to be
marked clearly with a laser warning logo.
A laser warning logo with laser wavelength information must be put up on all
entrance doors, preventing anyone from entering the room when the laser is
emitted and being exposed to laser radiation.
Each entrance door has to be equipped with a warning light. Every time the laser
is switched on the warning light has to come on and be illuminated to the outside.
Interlock shall be installed at each entrance and connected to the remote
interlocking connector on the rear panel of the device. When the door is opened,
the device can not emit laser.
7.1.2 Laser radiation protection at windows
All openings to the exterior of the laser room including windows must be properly
secured to prohibit the escape of laser beams, resulting in danger.
7.1.3 Protection against high reflective Surface
To avoid any direct or indirect scattered radiation from the laser beam, no highly
reflective material should be found in the treatment room. This includes mirrors,
picture frames, polished chromium surfaces and windows. All such surfaces have to
be removed or protected by non-reflective material.
7.1.4 Warning Labels of the Entrance
A laser warning label must be put up on all openings to the exterior of the laser room
including windows.
7.1.5 Fire Hazards
Do not work with the device and the laser beam close to flammable, anesthetic or any
other solvents which are easily flammable. Remove the paper and plastics from the
laser working area. Within a certain distance, these materials absorb considerable
energy can be ignited.
When the laser is not in use or patients are changed or a break in the treatment occurs
please turn the device into “Standby” status or just switch off the device.
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7.2 Warnings for patients, operators and other personnel
It is strongly recommended that users receive related training and carefully read the
instructions to be familiar with the basic operation and safety regulations before use.
Nominal Ocular Hazard Distance (NOHD)：NOHD identifies the beam
irradiance or the amount of irradiation is equal to the distance of the maximum
permissible exposure (MPE) of the cornea. The product has a NOHD of
3.43Km. In other words, in the absence of any defensive situation, the distance
between the human eye and the laser emission point must exceed 3.43Km.
Laser direct radiation or scattered radiation can cause irreversible damage to
the cornea, retina, and skin tissue. All Individuals present during the operation
of this device must wear protective goggle with an optical density of 5.0 or
greater at 980nm wavelength.
Never attempt to view the laser beam or the indicator light along an optical
path with eyes or with optical device, which may cause irreparable damage to
the eyes.
Do not remove the protective goggles until the operator returns to the standby
mode.
In the course of use, do not move the laser irradiation area to an unspecified
treatment site.
In the course of treatment, a minimum distance of 3cm should be maintained
between the laser output handpiece window and the patient's skin. And the
treatment time is generally 3-5 minutes. In the course of treatment, the doctors
must always pay attention to the treatment of patients to avoid skin redness,
burning and other adverse reactions.
When connecting or removing the handpiece, make sure that the device is in
standby mode or switched off.
Do not place the laser in READY mode to avoid unnecessary hazards in
standby mode.
Do not allow non-personnel to enter the treatment area during laser treatment
to avoid any laser radiation.
Do not wear any reflex jewelry or items during treatment. Avoid scattering or
reflecting laser energy that may cause damage to eyes or skin.
The handpiece must be placed in the working area of the medical personnel
who is responsible for the treatment and only can be operated by full-time
personnel.
Users should wear medical plastic gloves, use alcohol (or lens paper) to clean
the probe end and handpiece until the alcohol is completely evaporated before
using the device.
When the laser device is not being used, please turn off the power switch and
remove the key to prevent non-designated personnel or unauthorized persons
from operating the device.
When the device is working, if there is any abnormality (such as crash, no
display, light abnormality, etc.), press the emergency stop switch immediately
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and turn off the device. To identify the reasons before deciding whether to
operate. If necessary, please contact the designated dealer or K-Laser for help.
If the device does not work properly, please contact the company or dealer for
consultation immediately. Do not disassemble the device without guidance or
permission by unauthorized persons to avoid the serious, irreversible harm on
human body and device that caused by the possible electric shock.
No strong pull, extreme bending fiber in the course of the use. Failure to do so
may cause a loss of laser transmission efficiency, which may result in a
decrease in the therapeutic effect. In severe cases, fiber breakage may damage
the optical transmission system or cause unknowable damage to the user (or
patient).
It is strongly recommended that the device be inspected and maintained
regularly.
To avoid risk of electric shock, this equipment must only be connected to a
supply main with protective earth.
7.3 Safety warnings pertaining to the operation of the equipment
7.3.1 Warnings
Please choose a well-ventilated location for device installation. A minimum
distance of 20 cm should be maintained between the ventilation slots and the
walls to avoid the temperature rise. Otherwise, the treatment instrument could
not work, or even damage to the laser would be caused.
Strong electromagnetic environment may affect the normal operation of
device. It should also be avoided that the device is together used with other
easily interfered devices.
Unauthorized accessories (e.g handpiece, protective goggles, key switches,
interlock, etc.) may cause laser radiation hazards and damage to device. Please
use the related accessories specified by our company.
Before moving or lifting the laser device, please turn off the device and protect
the handpiece, fiber and the laser window with a dust cap from dust.
Check the integrity of the beam transmission system before use：A good way
to check the integrity of the transmission system is to have the aiming beam
pass through the same transmission system as the working beam. If the light
spot of the aiming beam is not at the end of the transmission system, or its
intensity is reduced or does not appear to converge, this may indicate that the
transmission system is damaged or not working properly.
The use of flammable anesthetics or oxidizing gases must be avoided, such as
nitrous oxide (N2O) and oxygen. Certain materials, such as cotton wool, are
oxygen-rich and will be ignited by the high temperature generated by the laser
device being use. Solvents and flammable solutions used for cleaning and
disinfection should be volatilized before using the device. It should be noted
that there is a risk that the internal gas may be ignited.
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7.3.2 Storage and use of the environment
The followings are the environmental conditions for the storage and use of the
device.
Storage Temperature: 0~35℃ (With packaging)
Operating Temperature: 10~30℃
Storage humidity:＜80% (With packaging)
Use ambient humidity: 30%~75%
Operating environment：86~106kPa
Altitude
Avoid direct sunlight, rain is strictly prohibited
Well ventilated
Avoid storing in strong electromagnetic environment
Avoid severe vibration
Avoid storing in explosive, corrosive gases, excessive dust or salt of the
environment
：≤
2000m
7.4 Safety Signs
The device has the following label affixed at the relevant location informing the user
of the safety-related information of the device and to warn the user that the laser has a
radiation hazard to avoid direct exposure or scattering of laser light to the eyes and
skin.
See 14 parts of product identification and packaging instructions.
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7.5 Safety functions
The Platinum Laser System provides some special safety function devices such as key
switch, emergency stop switch and remote interlock. These devices are used for
identification or emergency interruption, etc. All users of this product should be
familiar with the purpose of these safety devices and methods of operation.
Caution - Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure.
7.5.1 Emergency Stop
ON OFF
As shown, the switch is located on the front panel of the SAT-G30 for emergency
interruption of the laser output. When the device is working, if there is abnormal
working (such as crash, no display, light abnormal, etc.), immediately press the
emergency stop switch to stop the laser output. Reset the emergency stop switch to
restore power to the system, at which point the laser can not emit the laser. Please
reset the parameter and press the handpiece to emit the laser.
Follow the direction of the arrow on the emergency stop switch, turn the emergency
stop switch or pull up the emergency stop switch to reset the emergency stop switch.
7.5.2
As shown, the remote interlock is located below the rear panel of the device. The
remote interlock should normally be connected to an interlock (normally closed
switch) on the entrance door of the room. And its head should be connected to the
remote control interlock interface. When the door is opened, the device can not emit
laser, preventing anyone from entering the room when the laser is emitted and being
exposed to laser radiation.
Remote Interlock
Note: There is a red dot on the connector. Insert the interlock with the red dot facing
upward as the picture shows above.
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7.5.3
The indicator lights are located on the right of the LCD panel for power, remingding,
laser output prompts.
1) When the device is turned on, the power indicator light is green;
2) When the laser is emitting, the corresponding indicator light is yellow
3) When the warning state occurs, the corresponding indicator light is red.
Indicator lights
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