Asclepion MCL 31 Dermablate User manual

182099015-V01-10.Juni2013-GA-MCL31-THAI
User Manual
MCL 31 Dermablate
Dermatological Er:YAG Laser

182099015-V01-10.Juni2013-GA-MCL31-THAI
WARNING
The MCL 31 Dermablate laser device emits high levels of infrared
radiation that may cause serious damage to the eyes if it is used
improperly. Further risks are also possible.
Therefore, this User Manual must be studied carefully before using the
device and all warnings and instructions observed during its operation.
It is particularly important that all persons in the room in which the laser
is operated put on appropriate eye protection while the laser is in
operation.
Asclepion Laser Technologies GmbH
Brüsseler Str. 10
D - 07747 Jena
Germany
Tel.: [phone] / 7700 - 401
Fax: [phone] / 7700 - 402
E-mail: [e-mail]

182099015-V01-10.Juni2013-GA-MCL31-THAI

Contents
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Table of contents
1Introduction...............................................................................1
1.1 Overview ...................................................................................................... 1
1.2 Symbols in the User Manual......................................................................... 1
1.3 Intended use................................................................................................. 2
1.4 Copyright...................................................................................................... 3
2Safety.........................................................................................4
2.1 Overview ...................................................................................................... 4
2.2 Electrical hazards......................................................................................... 5
2.3 Biological hazards ........................................................................................ 5
2.4 Radio interference........................................................................................ 5
2.5 Laser ............................................................................................................ 6
2.5.1 Optical hazards caused by laser emission..............................................................6
2.5.2 Laser-induced fire hazard.......................................................................................8
3Technical data...........................................................................9
3.1 Device models.............................................................................................. 9
3.2 Specifications ............................................................................................... 9
3.3 Technical description.................................................................................. 11
3.4 Safety units................................................................................................. 12
4Start up ....................................................................................16
4.1 Deliverables................................................................................................ 16
4.2 Installation.................................................................................................. 17
4.2.1 Device design.......................................................................................................17
4.2.2 Labels on the device.............................................................................................18
4.2.3 Overview of the installation...................................................................................24
4.2.4 Door interlock connection .....................................................................................25
4.2.4.1 Terminals for Spot Identification & Fume Extraction ............................................................26
4.2.5 Foot switch...........................................................................................................26
4.2.6 VarioTEAM handpiece..........................................................................................27
4.2.7 Equipotential terminal...........................................................................................27
4.2.8 Mains connection..................................................................................................27

Content
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4.3 Switching on ...............................................................................................28
5Operation of the device..........................................................30
5.1 Overview of operation.................................................................................30
5.2 Settings for your laser device .....................................................................31
5.2.1 Parameters .......................................................................................................... 32
5.2.2 Special function/Tools.......................................................................................... 33
5.2.3 Activating the laser ready mode and releasing laser beam emission.................... 34
5.2.4 Changing the handpiece ...................................................................................... 35
5.2.5 Switching off the device........................................................................................ 35
6Application..............................................................................37
6.1 Overview.....................................................................................................37
6.2 General treatment information....................................................................38
6.2.1 Advisory Notes on Treatment............................................................................... 40
6.2.1.1 Typical Indications ................................................................................................................42
6.2.1.2 General Advice for Treatment...............................................................................................42
6.2.1.3 Pre-Therapy Action...............................................................................................................43
6.2.1.4 Treatment Techniques..........................................................................................................43
6.2.1.5 Procedure..............................................................................................................................45
6.2.2 Contra-indications................................................................................................ 48
7Accessories ............................................................................50
8Cleaning, disinfection and sterilization.................................51
8.1 General Rules.............................................................................................51
8.2 General recommendations for cleaning, disinfection and sterilization of
handpieces .................................................................................................52
8.3 Special recommendations for cleaning, disinfecting & sterilizing
accessories.................................................................................................54
9Fault messages and fault clearance......................................56
9.1 Overview.....................................................................................................56
9.2 Fault messages and fault clearance...........................................................57
10 Customer service...........................Error! Bookmark not defined.

Contents
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11 Regular maintenance, safety checks and calibrationError! Bookmark not defined.
11.1 Routine maintenance.....................................Error! Bookmark not defined.
11.2 Regular safety check.....................................Error! Bookmark not defined.
12 Disposal......................................... Error! Bookmark not defined.
13 EC compliance declaration........... Error! Bookmark not defined.
A Appendix: Manufacturer’s EMC declarationError! Bookmark not defined.

Introduction
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1 Introduction
1.1 Overview
•This User Manual contains the information required for the intended use of the device.
•It is an integral part of the complete product according to the applicable national,
European and international product liability directives and laws.
•Its most important objective is to protect individuals against risk situations and the device
against damage caused by improper use.
•Regular maintenance according to the instructions given in this manual increases the
precision and ease of operation of the device during its entire working life.
•In case of malfunctions or errors that are beyond the User's capabilities, contact
Asclepion's Engineering Department.
Knowledge of this User Manual is required to operate the device. Therefore, please familiarize
yourself with the contents and pay special attention to information concerning its safe operation.
1.2 Symbols in the User Manual
In this manual, the following symbols are used to draw your attention to dangers or to give
instructions on operating the device:
DANGER
This symbol indicates a direct danger for an individual's life and health.
Non-compliance with these instructions causes serious danger to health, including
life-threatening injuries or even death.
WARNING
This symbol indicates a possible danger for an individual's life and health.
Non-compliance with these instructions can cause serious danger to health, including
life-threatening injuries.
CAUTION
This symbol indicates a possible dangerous situation.
Failure to obey these instructions can cause injuries.
Important information
This symbol indicates important information about the proper use of the device. Failure
to obey these instructions can cause damage to property or malfunctions of the device
or its surroundings.
Tip
This symbol indicates practical tips and particularly useful information that enables the
User to use all the features of the device to best effect.

Introduction
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1.3 Intended use
Recommended use
Operating at a wavelength of 2.94 µm, which corresponds with maximum water absorption, the
MCL 31 Dermablate Er:YAG laser is perfectly suited for precise superficial skin ablation or cut-
ting, skin vaporization and skin coagulation.
Typical indications are: sebaceous adenoma, acne scars, epidermal nevi (soft), exophytic scars
(flat scars, no keloids), wrinkles ("skin resurfacing"), lentigines (simplex, senilis), nevi spili,
stepped scars, seborrhoeic keratosis, syringomas, xanthelasmas.
The MCL 31 Dermablate is also intended for ablative fractional skin resurfacing.
Please refer to chapter 6Application for detailed information about the use of this device.
WARNING
Incorrect use of this device can cause serious danger to health. Therefore, all warnings,
instructions and information in this User Manual are to be observed under all
circumstances! Non-compliance is considered as misuse of the device!
No modification of this medical device is allowed!
Contra-indications
CAUTION
The intensive laser light in the infrared range can cause thermal damage to skin
structures. The contra-indications listed below are based on clinical experience in
operating laser devices for said purposes obtained over about 15 years. They do not
claim to be complete or valid indefinitely.
•Microbiological infections (e.g. impetigo, herpes, pustular acne)
•Heavily tanned skin
•Patients with known unreasonable UV-light exposure
•Tendency to hypertrophic scarring or keloids (perform a trial treatment in these cases)
•Pregnancy

Introduction
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Restriction in use
WARNING
The laser emissions from the device can cause thermal changes to tissue structures.
Nobody other than a practicing physician or under the supervision of a practicing
physician (hereinafter referred to as user for simplification) may use the device.
Active medical products may only be applied by users who are adequately qualified to
do so, based on their professional training background, expert knowledge and practical
experience.
It is expressly pointed out that the device may be used only by persons who have
been instructed in its operation and confirmed their attendance on the training course
by signing the Medical Device Logbook.
Among other institutions, Asclepion Laser Technologies GmbH also offers courses for laser
expertise in medical applications.
Medical Device Directive/Medical Product Act
The MCL 31 Dermablate meets the requirements of EC Medical Device Directive
93/42/EEC and its German equivalent in the form of the German Medical Product Act
(MPG).
Device type acc. to 93/42/EEC: II b
UMDNS no.: 17-768 Laser, therapeutic
1.4 Copyright
Specifications may change due to further technical development. Contact the Engineering
Department of Asclepion Laser Technologies GmbH or your local distributor of Asclepion Laser
Technologies GmbH equipment to get the latest information.
© Unless expressly authorized, distribution and duplication of this document and utilization
and disclosure of its contents are not permitted. Violations will incur an obligation to pay
compensation.
All rights reserved in the event of granting of patents or registration of a utility model.

Safety
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2 Safety
2.1 Overview
The MCL 31 Dermablate complies with the requirements of the EC Medical Device Directive
(93/42/EEC) and the German Medical Product Act (MPG).
The MCL 31 Dermablate is a Class IIb medical device as defined in the directive in Annex IX (i.e.
a surgical invasive product that is intended to have a biological effect –this must not be confused
with the laser class!).
Like each device, the MCL 31 Dermablate may lead to potential risks when operated. The user
should be aware of them before starting the system. Among these risks are optical, electrical and
biological dangers as well as fire hazards.
Observe the national regulations applicable for the operation of a medical product.
According to the EC Medical Device Directive (93/42/EEC), users in the European Union are
obliged to keep a Medical Device Logbook. A corresponding example is delivered with the device.
WARNING
The laser device emits high levels of radiation in the infrared range that may cause
serious damage to the eye if it is used improperly.
It is mandatory to observe the instructions given in this User Manual for the equipment
and its operating, maintaining, checking or calibrating procedures.
WARNING
The device's laser radiation, however low, carries a risk of fire. Under no circumstances
may the device may be used in an explosive atmosphere (classified as AP and APG
under IEC 601-1). Take care to preclude vapors from solvents or flammable liquids
(these may have been used for cleaning or disinfection) in the room before you start
working with the laser.
WARNING
Please note that this product is subject to scheduled technical safety tests that must be
performed at annual intervals to ensure safety for staff and patients. If the tests are not
performed regularly, serious health problems may arise.
The results of such safety tests are to be reported in the Medical Device Logbook.
WARNING
Servicing, repairs or modifications may not be performed by anyone other than
Asclepion Laser Technologies GmbH personnel or other bodies duly authorized to
handle such work, to ensure safety of the staff and patients.
If unauthorized persons carry out servicing, repairs or modifications of the device
serious health problems may arise.
WARNING
The instrument must be installed and operated according to CAN/CSA-Z386-92: Laser
safety in health care facilities.

Safety
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2.2 Electrical hazards
WARNING
The laser is operated with mains power. There is a risk of electric shock! Do not open
the device unless you are trained and authorized to do so.
The device is only to be operated with reliably grounded and correctly installed sockets
with grounding contact.
WARNING
The laser is operated with mains power. There is the risk of electric shock!
The device is designed to prevent liquids penetrating it in normal use. If liquid
penetrates the inner system space or the handpiece in exceptional cases, you must
turn the power off and pull out the mains power plug. Please contact our Engineering
Department.
2.3 Biological hazards
WARNING
The handpiece spacer is in contact the patient’s skin during the treatment. There is the
risk of micro-organisms being transferred.
The selected spacer must be deep cleaned and disinfected directly after each
application!
2.4 Radio interference
The device complies with the requirements of the EN 60601-1-2 standard. The system is not
affected by electromagnetic interference generated by other devices that conform to the same
standard. Moreover, the system does not generate electromagnetic radiation beyond the limiting
values indicated in EN 60601-1-2. The manufacturer’s electromagnetic compatibility declaration
according to EN 60601-1-2 is enclosed with this manual.
WARNING
Medical devices are subject to specific electromagnetic compatibility (EMC)
precautionary measures. The device emits low levels of electromagnetic radiation that
may have an effect on devices that do not comply with the standard. Unintended
settings at these devices could be the result of such an effect.
Please observe the notes in the manufacturer’s EMC declaration in the Appendix when
installing and operating the device.
WARNING
The device may be influenced by devices that do not comply with the standard
indicated above. The result may be unintended settings. Therefore, switch off
cellphones and similar equipment before operating the laser device.
WARNING
The use of accessories and cables not authorized by the manufacturer may result in
increased interference emissions or decreased immunity of the device with the above
mentioned consequences.
Use only accessories and cables that have been authorized by Asclepion Laser
Technologies for the purpose

Safety
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WARNING
The device must not be stacked/collocated or in combination with other devices. If the
device is operated close to or with other devices, you must check that the device is
working properly in this arrangement.
2.5 Laser
2.5.1 Optical hazards caused by laser emission
Lasers are classified in accordance with their potential for danger. The most dangerous class is
class 4 (the least dangerous class 1).
WARNING
The device is a class 4. That means that direct and even scattered laser radiation from
the device can cause serious damage to the eyes if it is operated improperly.
The protection measures described below must be strictly observed.
It is particularly important that all persons in the room in which the laser is operated put
on appropriate eye protection while the laser is in operation.
For fundamental rules on the handling of laser devices, you should refer to the international
standard EN 60825. It is complemented by national regulations providing general protection from
dangerous laser radiation. Their purpose is to protect operating personnel and patients during
medical applications.
Please follow specific national regulations that may be valid for your location.
It is highly recommended that you follow the rules specified below:
1. A laser protection officer should be appointed in writing, having at least the following
responsibilities:
•monitoring of laser operation,
•supporting the user on safe operation issues and necessary protective measures,
•cooperating with expert personnel on occupational safety in fulfilling their tasks,
including information about important laser radiation protection issues.
2. Laser area
During operation, the area where the maximum permissible radiation level may be
exceeded, i.e. the so-called laser area must be delineated and marked with a laser
warning sign. The laser area is the room in which the laser is used. Warning lights and a
yellow triangular laser warning label must be provided at all access points.
Figure 1: Laser warning label (European)

Safety
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3. The NOHD (Nominal Ocular Hazard Distance) of this laser system is extremely large, so
the entire laser session room is to be regarded as the laser area.
4. Personal eye protection
WARNING
Laser radiation can cause serious damage to the eyes.
Everyone present in the laser room during a treatment session must wear laser safety
goggles and patients an eyeshield!
Laser safety goggles and eyeshields must comply with the specifications defined in the
technical data section!
5. Further precautionary measures
•Cover up windows and other openings of the treatment room in order to prevent
unwanted laser radiation emission.
•Restrict access to the treatment room to the patient to be treated and to those
persons who will assist and are trained in the handling of this laser device.
•Make sure that personnel trained and assisting in a therapy session know how to
shut down the laser in the case of an emergency.
•Remove all metal objects such as watches, rings, bracelets or similar belongings
from the working area and refrain from the use of reflecting instruments or other
comparable materials where possible.
(Reflecting objects can interrupt the laser beam and guide it to an area other than
that intended. Many surfaces, even those that appear matt, can strongly reflect the
emission wavelength of the laser.)
•Point the active laser only onto the intended treatment area.
•Refrain from looking directly into the outlet opening of the handpiece or that of the
optical fiber, even if you wear laser safety goggles.
•For non-operational phases, you should switch to STANDBY mode (in the STANDBY
mode, accidental firing of the laser is prevented).
•Always remove the key from the key holder once power has been turned off and
keep the key in a safe place.
6. Responsibility
The user who fires the laser is responsible for laser safety. He/she has to ensure that all
preventive measures have been taken before firing the laser. It is particularly important
that all persons in the room, in which the laser is operated, including the patient, put on
the appropriate laser safety goggles or eyeshield.

Safety
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2.5.2 Laser-induced fire hazard
WARNING
Because of the laser radiation from the devices, there is a risk of fire or explosion if the
laser is used in the presence of flammable materials, solutions or gases or in an
environment that is enriched with oxygen.
Users should take the following precautions to prevent fires caused by laser radiation:
•Expose only the proposed body areas to laser emission
•Use non-flammable substances for preparing the treatment and for cleaning and
disinfecting handpieces directly before and during treatment. If it is not possible to
avoid using solvents such as alcohol or isopropyl alcohol directly before and during
treatment, the vapor should be removed by aeration before firing the laser or at
least a pause observed.
•Use non-flammable substances for anesthesia, if at all.
•Avoid the use of oxidizing gases, e.g. nitrous oxide (N2O) and oxygen. Be especially
careful when using oxygen. Oxygen increases both the intensity and the extent of
fire.
•Keep a minimum of flammable materials in the treatment room. If the treatment
must use flammable materials, moisten them.
•Keep clothes as far as possible away from the treatment zone.
•Some materials, which are saturated with oxygen (e.g. cotton), could be ignited at
the high temperatures which develop when the laser is used as intended.
•Always have a small fire extinguisher and water ready in the treatment room

Technical data
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3 Technical data
3.1 Device models
Designation
Part
Number
Description
MCL 31 Dermablate
1820
Er:YAG Laser (main unit)
VarioTEAM Handpiece
4075
Standard handpiece for skin ablation (1-6mm)
VarioTEAM XL Handpiece
4076
Standard handpiece for skin ablation (8-12 mm)
MicroSpot Zoom Handpiece
4077
Handpiece for fractional skin resurfacing
The standard delivery includes the main unit with VarioTEAM Handpiece.
The VarioTEAM XL Handpiece and the MicroSpot Zoom Handpiece can be obtained optionally.
3.2 Specifications
Specification
MCL 31 Dermablate
Device model
Floor-based unit
Display
Display with capacitive push-buttons below glass plate
Operator guidance
Touchscreen
Cooling
Coolant
Internal cooling cycle
Distilled water only
Door interlock connector
5V/10mA
Laser warning lamp
Potential-free relay contact
max. 24V/1A (make contact)
Permissible ambient
conditions
Temperature: 15°C to 30°C
Rel. air humidity: max. 85% (no condensation)
Height: max. 2000m above sea level
Permissible transport and
storage conditions
Temperature: 10°C to +70°C
Rel. air humidity: max. 90% (no condensation)
Dimensions
360 × 600 × 930 mm (W × D × H)
without mirror arm and handpiece
Weight
approx. 75 kg
Power requirements
230V/50Hz max. 2500W
120V/60Hz max. 2500W
Main fuse
overcurrent release 16A, medium slow-blow
Overvoltage category
II (IEC 60664-1)
Peak mains voltage
Max. nominal mains voltage
V MT peak = 2500V peak
V MN rms = 300V rms

Technical data
10 182099015-V01-10.Juni2013-GA-MCL31-THAI
Classification according to
directive 93/42/EEC
II b
Accessories
See chapter 7 Accessories
Operating mode
The device has been designed for continuous operation
Smoke evacuation
Inbuilt smoke evacuation with three-stage filter system
Specification
Laser
Laser model
Er:YAG laser (solid state laser)
Wavelength
2940 nm
Laser class
4
Required laser safety goggles
(As specified in DIN EN 207: 2009)
2940 nm I LB4
Pulse duration
100/300/600/1000 µs (Ablation mode)
600 µs (Thermal mode)
Pulse energy
max. 2.5J
Pulse frequency
1/4/8/10/12/15/20 Hz (Ablation mode)
20 Hz (Thermal mode)
Spot sizes (handpieces)
VarioTEAM handpiece: 1/2/3/4/5/6 mm
VarioTEAM XL handpiece: 8/10/12 mm
MicroSpot Zoom handpiece: 13 ×13 mm
169 spots, diameter 350 - 600 µm
10 –25% coverage
Output power tolerance
± 10%
Laser beam mode
Multimode
Laser beam diameter at the
handpiece output
See spot sizes
Ablation mode: 2 –250 J/cm2
Energy density
Thermal mode: 1.5 J/cm2
MicroSpot mode: 2 –75 J/cm2(max. sequence of 15
pulses)
Beam divergence at the handpiece
output (round angle, 1/e2)
Max. 80 mrad (4.5°)
Nominal ocular hazard distance
(with handpiece)
2 m

Technical data
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Protection class of the part used
B
Beam delivery:
Articulated mirror arm with VarioTEAM handpiece
Optionally: MicroSpot handpiece
Pilot laser:
Laser diode, 635 nm, < 2 mW, selectable intensity
class 2 laser
Fume extraction:
Built-in functionality
3.3 Technical description
Laser
The actual laser consists of a laser head, an optical resonator and a laser bench. The laser head contains
an optical reflector that projects multi-spectral light from a pulsed flashbulb into the laser rod. Light is
generated by optical excitation of the laser rod. This light is then bundled within the optical resonator. The
resonator itself consists of two mirrors, one at each end of the laser head. They are aligned parallel to
each other. One mirror provides 100% reflection, with the other mirror reflecting only part of the beam,
while allowing the remaining laser energy to pass through as useful laser light. The laser bench provides
mechanical support for the laser head and the resonator. It also accommodates further functional compo-
nents such as an energy measuring head, a pilot laser beam injection module and a mechanical beam
shutter. The therapy laser beam, which is coaxially aligned with the pilot laser beam, is directed onto an
articulated mirror arm to be passed on to the handpiece.
Laser beam delivery
The beam delivery system is a photo-mechanical assembly consisting of an articulated mirror arm and a
handpiece (see Figure 5: ). It transmits laser light to the point of treatment.
The articulated mirror arm is mechanically attached to the MCL 31 Dermablate. It consists of seven mir-
rors mounted onto swing-motion hinges. The motion range of the articulated mirror arm covers a radius of
approximately 160 cm. Transmission losses are compensated by appropriate calibration of the internal
energy meter.
The handpiece is screwed to the articulated mirror arm with its distal end and is detachable. It has two
terminals for extraction of ablation products and one electrical terminal for identification of the diameter of
the therapeutic beam. To alter the size of the treatment spot, rotate the ring on the handpiece (Figure 5: ).
Operation
The laser is fired with a foot-operated switch (footswitch). The footswitch is designed to control the flu-
ence (energy density) of the laser pulses without the need to operate the display.
.

Technical data
12 182099015-V01-10.Juni2013-GA-MCL31-THAI
3.4 Safety units
The device is equipped with several safety units that have been provided to avoid maloperation
and unintentional activation of the system. All those who operate the laser or assist during
treatment should familiarize themselves with these units.
Laser emergency STOP switch
The red Laser emergency STOP switch at the front of the device (see figure below) is for the
purpose of switching off the system immediately in an emergency. It should only be activated in
emergency situations, i.e. if the emission has to be interrupted immediately.
Press this button to turn off the system immediately. To unlock this button after eliminating the
emergency, turn it to the left until it springs out again.
Note
The Laser emergency STOP switch should not be used to turn the system on and off in
its normal condition.
Key switch
The key switch is used to activate the system. Only authorized persons having access to the
switch can start the system. The system can only be started via the key switch, if the Laser
emergency STOP switch has not been pressed.
WARNING
The laser device emits strong radiation in the infrared range. This radiation can cause
serious eye injuries if the device is not properly used.
The device must not be switched on or operated by unauthorized personnel.
Always remove the key after having switched off the system and ensure that it is kept
by authorized persons only.
Key switch
Laser STOP switch
Figure 2: Safety units on the front panel of the device