Reveal REGAL User manual

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REGAL User Operating Manual | 3
This document or its contents may not be provided to third parties or copied without express written permission
from the manufacturer. All rights, including prototype protection, are reserved. ©revealTM

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Content
1: Chapter 1: System overview 07
2: Chapter 2: Installation 09
3: Chapter 3: Safety and Technical acceptance 10
4: Chapter4: Environment protection and clinical indication 15
5: Chapter 5: Product Description 16
6: Chapter 6: Operating instruction 22
7: Chapter 7: Failure Detection 30
8: Chapter 8: Maintenance and Service 32
9: 34

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1.1
1.2
1.3
Introduction
Theory and Technical Information
Transportation and Storage
Thank you for choosing the REGAL medical diode laser system.
REGAL is class 4 laser. Care is required to avoid hazards or injures. Please read the operation
manual carefully before operating. If you have further questions which are not answered by
this manual regarding safety, application or operating of the device please get in touch with
revealTM (See sales and service information, paragraph 13) or your local distributor.
The intended use of revealTM medical diode laser system is surgical operations include tissue
cutting, tissue vaporization and concreting.
Copyright
parts of the revealTM copyright with all rights reserved. Any person or company will bear legal
liability for counterfeit.
Under the copyright laws, this manual cannot be copied in whole or in part without the
express written permission of revealTM. Permitted copies must carry the same proprietary
Diode laser is a kind of laser with semiconductor as working material. It consists of working
material, cavity resonator and power source.
The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm.
3.1 Information on the packaging
NOTE:
The symbols printed on the outside are for transportation and storage, and have the following
meaning:
1. System overview

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This end up.
Keep away from moisture.
Do not turn over.
Temperature extremes.
Fragile – handle with care.
Not to be stowed under other cargo.
The REGAL should only be transported and stored in its original container to prevent damage.
Extreme movements during the transportation should be avoided.
The device should avoid any contamination of acid, alkali or caustic material. Protect it from
direct exposure under the sun or the rain.
1.3.2 Transportation and storage conditions
The ambient air has to be dry (less than 80%) and clean. The temperature ranges from 0 to
55 °C, and the atmospheric pressure ranges from 500hPa to 1060hPa.

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2.1 Unpacking and installation
In most of the cases the device should be unpacked and installed by revealTM or one of the
representatives who is responsible for the tests and inspections on the spot.
The product is well packed before transportation. Please check carefully whether there is any
damage to the package after you receive it.
When unpacking, please check whether all the items are inside according to the packing list
and save them with care, for them will be in demand when you return the product to revealTM.
If you have any questions, please contact revealTM or authorized distributor immediately.
2.2 Requirements to the Room
The use of a medical Class 4 laser requires warning signs on the unit itself and clear signage
at the entrance to the room. Please refer to the information below for further instruction.
2.2.1 Labelling of the Entrance
Each entrance door has to be marked clearly so that from the outside the laser room can be
recognized immediately.
doors.
on the warning light has to come on and be illuminated to the outside.
2.2.2 Laser protection at windows
During surgery, it is important that no laser light can escape from the room. All openings to
the exterior of the laser room including windows must be properly secured to prohibit the
escape of laser beams. If you need information or help in designing the room please get in
touch with revealTM or your local distributor.
material should be found in the surgery room. This includes mirrors, picture frames, polished
2.3 Safety indicators
where the laser or laser radiation could escape.
2. Installation

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3.1 General
The “REGAL” is a precise medical laser device and can only be used for medical application.
The system has been thoroughly developed and will be thoroughly tested before shipment.
To enjoy your product through the lifetime and to protect you and your personal from laser
radiation we recommend reading this chapter very carefully. In addition, the person to
operate the unit should get relative professional training before using.
Class 4 describes only high energy lasers and therefore needs certain precautions before
Caution!
3.2 Eye Protections
Attention!
To avoid any eye injuries, in the treat room where safety goggles placed has to be clearly
marked. All the people including patients have to wear safety goggles as soon as the laser is
turned on.
you have further questions about safety goggles please get in contact with revealTM or your
local distributor.
3. Safety Tips and Technical Acceptance

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3.3 Electrical Protection
from revealTM or the distributors. revealTM will not take any responsibility if any other person
opens the device without the approval of revealTM or the distributors.
there is no water drop or water vapor when the device is turned on.
Attention!
3.4 Fire Hazards
Danger!
When the laser is not in use or in between patients, or if there is a break in the treatment,
the foot switch.
3.5 Protection against scattered light
please follow the connection sequence described below:
(2) Connect the laser handpiece
(3) Switch the laser on

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the doctor who is performing the treatment. Never trigger the laser via a third person.
3.6 Main Switch and Key Switch
The main switch of the unit is a power switch at the back of the device and the key switch is
at the front panel. The device is equipped with two keys and cannot be operated without a
the system, turn the main switch to “|” position and turn the key switch into “|” position. The
menu.
3.7 Manual Reset
Any improper function of the system will immediately cut the electric supply to the laser
then “I” position. If the failure shows up repeatedly, please contact revealTM or the authorized
distributor at once.
3.8 External interlock connector
3.9 Safety Signs
CAUTION
CLASS 4 LASER RADIATION WHEN OPEN
AND INTER LOCKS DEFEATED
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
Danger for laser Laser output window External interlock connector on
STOP
Laser Interlock Fiber
The external interlock connector By default, the
external interlock connector is disconnected.

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B type device Refer to operate manual
2011-03-21
Production date Manufacturer

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Numerical aperture of Fibre (NA)
Fibre diameter (d)
Maximum energy (EO)
(Plus margin of error) E
Frequency at maximum energy 8 Hz
Maximum ermissible exposures (MPE) (engl.)
MPEPulse_Train
3 x (8Hz x 10s)
MPEPulse_Train
National Ocular Hazardous Distance (NOHD)
NOHD=
4 x E0– d
[m]
x MPEPulse_train
NOHD=
4 x 4.2 J – 200 µm
0.4436 rad
[m]
x 334 J/m2
NOHD= 0.28 m
3.10 NOHD, National Ocular Hazardous Distance

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4.1
4.2
Environmental protection
Clinical indications
with local health laws of the disposal of medical waste which comes in contact with the
human body.
“REGAL” will not generate any waste during normal use. If necessary, the REGAL can be
disposed according to local policy of conventional electric products.
The unit performs vaporization, incision and coagulation of the tissues with high power beam
surgery, gynecology, urology, dermatology and general surgery department.
The physician should be aware of the clinical applications for the laser when the exact therapy
of the diode laser in each clinical case cannot be known clearly.
The following therapies for kinds of diseases have had quite an amount of clinical reports.
They are only for Reference, and please look through the relative clinic reports for details.
Contraindications for use of REGAL:
Patients who have heart trouble, psychosis, hypertensive diseases or any patient who has
been determined as not suitable for laser therapy.
4. Environmental protection & and clinical indication

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5.2 Front Panel
Regal Front Panel:
(1) Laser Aperture (6) Alarm Indicator (RED)
(2) Key Switch (7) Handpiece Holder (ON THE SIDE)
(3) Color Touch Screen (8) Emergency Stop
(4) Power Indicator (GREEN)
(5) Laser Emission Indicator (Orange)
3
8
7
4
5
6
1
2
5.1 General Overview
(1) Laser system
(2) Color touch screen
(3) Fiber and the handpiece
(4) Foot switch
(5) Power detector
panel, safety shutter and the embedded computer control system.
5. Product description

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5.2.1 Laser Aperture
improperly connected.
Warnings!
removed, cover the laser aperture with the aperture cap immediately to prevent the aperture
from being contaminated.
Attention!
Clean the aperture cap with alcohol before use. But be careful not to leave any cotton yarn
or other material in the cap after the cleaning.
5.2.2 Key Switch
The key switch for the unit is at the front of the device. The device is equipped with two keys
and cannot be operated without a key. The key should only be carried or be available by the
physician who operates the device.
The key switch serves as the main system activator. Turning the key switch into “|” position,
Attention!

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5.2.3 Color Touch Screen
The LCD touch screen of the unit features high sensitivity and high resolution. Touch the
Attention!
5.2.4 Alarm Indicator
The alarm indicator will be red when the system alarms.
5.2.5 Laser Emission Indicator
The Laser emission indicator will be yellow when the laser is in operation. The action of the
indicator is synchronized with the laser.
status. At that time the system will stop all the output and the touch screen will show the
error information, during the system alarm.
Attention!
5.2.6 Power Indicator
The power indicator will be green if the power supply of the laser is normal.

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Attention!
5.2.7 Handpiece Holder
You can place the handpiece on the handpiece holder when you do not need to use it. The
following picture will help to install the handpiece holder:
5.2.8 Emergency Stop
pressing the emergency stop will immediately stop laser emission. Before restarting, turn as
the arrow shows at the knob to bounce up the emergency stop.

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5.2.10 Encode Knob
is not the same.
5.3 Rear Panel
REGA Rear Panel:
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