Asclepion MeDioStar NeXT User manual

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User Manual
MeDioStar
MeDioStar NeXT
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Contents
1590 99 002_1 - 21. Februar 2011
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1590 99 002_1 - 21. Februar 2011
WARNING
The laser device MeDioStar emits high levels of emission
in the infrared
range that may cause serious damage to the eye
if the device is used
improperly. Moreover, further risks are possible.
Therefore,
this User Manual must be studied carefully before using the
device and all warnings and
instructions are to be observed during its
operation.
It is of particular importance that all persons in the room in
which the laser
is operated put on th
e appropriate eye protection during the active laser
operation.
Asclepion Laser Technologies GmbH
Brüsseler Str. 10
D - 07747 JENA
Germany
Tel.: [phone] / 7700 - 401
Fax: [phone] / 7700 - 402
E-mail: [e-mail]
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Contents
1590 99 002_1 - 21. Februar 2011
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1590 99 002_1 - 21. Februar 2011
Table of contents
1 Introduction...............................................................................1
1.1 General information...................................................................................... 1
1.2 Symbols in the User Manual......................................................................... 1
1.3 Intended use................................................................................................. 2
1.4 Copyright...................................................................................................... 3
2 Safety.........................................................................................4
2.1 General information...................................................................................... 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
3 Technical data...........................................................................9
3.1 Device models.............................................................................................. 9
3.2 Specifications............................................................................................... 9
3.3 Technical description.................................................................................. 11
3.4 Safety units................................................................................................. 12
4 Start up ....................................................................................15
4.1 Scope of delivery........................................................................................ 15
4.2 Installation.................................................................................................. 16
4.2.1 Device design.......................................................................................................16
4.2.2 Labels at the device..............................................................................................17
4.2.3 General information about installation...................................................................21
4.2.4 Door interlock connection .....................................................................................21
4.2.5 Foot switch...........................................................................................................22
4.2.6 Handpiece with integrated skin cooling.................................................................23
4.2.7 Mains connection..................................................................................................24
4.3 Switching on............................................................................................... 24
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Contents
1590 99 002_1 - 21. Februar 2011
5 Operation of the device.......................................................... 26
5.1 General information on operation ...............................................................26
5.2 Setup..........................................................................................................27
5.3 Patient database.........................................................................................29
5.4 Library.........................................................................................................30
5.5 Asclepion Effect..........................................................................................33
5.6 Starting the treatment.................................................................................33
5.6.1 Start via Quickstart............................................................................................... 34
5.6.2 Start via Indication list.......................................................................................... 35
5.6.3 Start via Patient database.................................................................................... 35
5.7 Setting and saving parameters...................................................................36
5.8 Settings for your laser device .....................................................................37
5.8.1 Parameters .......................................................................................................... 38
5.8.2 Special function/Tools.......................................................................................... 39
5.8.3 Activating the laser ready mode and releasing the emission of the laser beam .... 40
5.8.4 Changing the handpiece ...................................................................................... 42
5.8.5 Switching off the device........................................................................................ 42
6 Application.............................................................................. 43
6.1 General instructions....................................................................................43
6.2 General treatment information....................................................................44
6.2.1 Interaction of laser beam and tissue..................................................................... 45
6.2.2 Classification of skin types ................................................................................... 47
6.2.3 Overview on zones sensitive to pain .................................................................... 47
6.2.4 Application parameters......................................................................................... 48
6.3 Typical indications overview ....................................................................50
6.4 Epilation......................................................................................................50
6.4.1 The target: anatomy of hair .................................................................................. 50
6.4.2 The phases of hair growth.................................................................................... 51
6.4.3 Selection of patients............................................................................................. 52
6.4.4 Contraindications ................................................................................................. 53
6.4.5 Possible side effects ............................................................................................ 53
6.4.6 Preparing laser epilation....................................................................................... 54
6.4.7 Test treatment...................................................................................................... 54
6.4.8 Treatment............................................................................................................. 55
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1590 99 002_1 - 21. Februar 2011
6.4.9 Post-op treatment.................................................................................................55
6.4.10 Follow-up treatment procedures ...........................................................................56
6.5 Vascular treatment..................................................................................... 58
6.5.1 Selection of patients.............................................................................................58
6.5.2 Contraindications..................................................................................................59
6.5.3 Possible side effects.............................................................................................60
6.5.4 Preparing the laser treatment ...............................................................................60
6.5.5 Test treatment ......................................................................................................61
6.5.6 Treatment procedure............................................................................................62
6.5.7 Post-treatment......................................................................................................62
6.5.8 Follow-up treatments............................................................................................62
6.6 Treatment of acne...................................................................................... 63
6.7 Skin rejuvenation........................................................................................ 64
7 Accessories.............................................................................66
8 Cleaning, disinfection and sterilization.................................67
8.1 General rules.............................................................................................. 67
8.2 General advice for cleaning and disinfecting the handpieces..................... 68
8.3 Special recommendations for cleaning and disinfecting the handpieces.... 70
9 Fault messages and fault removal.........................................71
9.1 General information.................................................................................... 71
9.2 Fault messages and fault removal.............................................................. 72
10 Customer service....................................................................74
11 Regular maintenance, safety checks and calibration...........75
11.1 Routine maintenance.................................................................................. 75
11.2 Regular safety check.................................................................................. 76
12 Disposal...................................................................................77
13 EC declaration of conformity .................................................78
A .........................79
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Introduction
1590 99 002_1 - 21. February 2011 1
1Introduction
1.1 General information
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 directives and laws on product liability.
The most important objective is to protect persons against risk situations and the device
against damages caused by improper use.
Regular maintenance according to the instructions given in this manual increases the
precision and operability of the device during its entire service life.
In case of malfunctions or errors that go beyond the scope of intervention of the User
contact the Technical Service of Asclepion.
Knowledge of this User Manual is required for the operation of the devices. Therefore, please make
yourself familiar with the contents and pay special attention to information concerning the safe
operation of the device.
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 the life and health of persons.
Non-compliance with these instructions causes serious danger to health up to life-
threatening injuries or even death.
WARNING
This symbol indicates a possible danger for the life and health of persons.
Non-compliance with these instructions can cause serious danger to health up to life-
threatening injuries.
CAUTION
This symbol indicates a possible dangerous situation.
Non-compliance with these instructions can cause injuries.
Important information
This symbol indicates important information about the proper use of the device. Non-
compliance with these instructions can cause damage to property or malfunctions of the
device or in its surroundings.
Tip
This symbol indicates practical tips and particularly useful information that enables the
User to use all the features of the device in an optimal manner.
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Introduction
2 1590 99 002_1 - 21. February 2011
1.3 Intended use
Recommended use
The MeDioStar NeXT is a pulsed diode laser (Class 4 laser product) that is used for the removal of
unwanted hair, for the treatment of acne, for vascular treatments and for skin rejuvenation. Melanin
and blood relatively strongly absorb the range of wavelengths of the radiation emitted by this laser,
whereas the surrounding skin absorbs only a little bit of it. In this way, the radiation thermally
destroys the target structure while protecting the surrounding skin.
Please refer to chapter 6 for detailed information about the use of this device.
WARNING
The incorrect using of this device can cause serious danger to health.
Therefore, all
warnings, instructions and informations of this User Manual are to be observed
under all
circumstances! The non-compliance is considered as unintended use of the device!
Any modification of this medical device is not allowed !
Contraindications
CAUTION
The intensive laser light in the infrared range can cause thermal damage of skin structures.
The contraindications listed below are based on clinical experience in operating laser
devices for said purposes of during about 15 years. They do not claim
to completeness or
unlimited validity.
Light sensitivity
Usage of preparations that increase sensitivity to light
Cellulite therapies in the treatment area (wait a few weeks)
Cancerous and pre-cancerous lesions in the treatment area
Haired nevi in the treatment area
Herpes simplex in the treatment area
Keloids in the treatment area
WARNING
The intensive laser light in the infrared range can cause thermal damage to the eyes.
Therefore it is NOT PERMITTED to laser the area of the eyes! Occasionally, eye
inflammation and a reduction of the visual function were observed although the eyes
were protected by eyeshields!
WARNING
The intensive laser light in the infrared range can cause thermal damage
to skin structures.
Therefore it is NOT PERMITTED to use laser treatment for pregnant women or children
because clinical studies do not exist for these patients.
CAUTION
Patients with tanned skin especially fresh tanned - develop more intensive side effects,
particularly subsequent pigment changes. They should postpone the laser epilation!
Tattoos in the treatment area cause stronger side effects, too. Moreover, the color will be
partly removed. Therefore, tattoos should not be treated.
Contraindications particularly for the treatment of spider leg veins
Superficial varices with a diameter larger than 3 mm
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Introduction
1590 99 002_1 - 21. February 2011 3
Branch and side branch varicose veins
Ulcer
Diabetes
Vasculitis
Stasis dermatitis
Podedema
Neuropathy of the legs
Corticosteroids treatment in the last three months
Thrombophlebitis
Restriction of use
WARNING
The laser emission of the device can cause thermal changes of tissue structures.
Treatment may not be performed by anyone other than a practicing physician or under
the responsibility of a practicing physician (hereinafter referred to as user for
simplification).
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
use of the device is only permitted for Users that have
been instructed to operate it and confirmed the training course by their signature in 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 MeDioStar NeXT
meets the requirements of the EC Medical Device Directive
93/42/EEC and of its German equ
ivalent in form of the German Medical Product Act
(MPG).
Device type acc. to RL 93/42/EEC: II b
UMDNS no.: 16-948 laser, therapeutic
1.4 Copyright
The specifications are subject to change due to further technical development. Contact the Technical
Service of Asclepion Laser Technologies GmbH or your distributor of Asclepion Laser Technologies
GmbH to get latest information.
© Unless expressly authorized, the forwarding and duplication of this document, and the
utilization and disclosure of its contents are not permitted. Violations will entail an obligation to pay
compensation.
All rights reserved in the event of granting of patents or registration of a utility model.
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Safety
4 1590 99 002_1 - 21. February 2011
2Safety
2.1 General information
The MeDioStar NeXT complies with the requirements of the EC Medical Device Directive
(93/42/EEC) and the German Medical Product Act (MPG).
The MeDioStar NeXT is a Class IIb medical device as per the directive in Annex IX (i.e. a surgical
invasive product that is intended to develop a biological effect that must not be confused with the
laser class!).
Like each device, the MeDioStar NeXT 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) the users in the European Union is
obliged to keep a Medical Device Logbook. A corresponding sample 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 the device is used improperly.
Absolutely observe the instructions given in this User Manual
for equipment and
procedures for operating, maintaining, checking or calibrating purposes.
WARNING
The laser radiation of the device
can cause, whenever low, the risk of fire. Under no
circumstances the device may be used in an explo
sive atmosphere (classified as AP and
APG under IEC 601-
1). Take care to preclude the existence of vapors from solvents or
flammable liquids (these have been possibly 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 the safety for the staff and patients. If
the tests
are not performed regularly serious health problems can be caused.
The results of such safety tests are to be reported in the Medical Device Logbook.
WARNING
Work for service, repair or modification may not be performed by anyone other than
Asclepion Laser Technologies GmbH personnel or other bodies duly authorize
d to handle
such work to ensure the safety for the staff and patients.
If unauthorized persons carry out service works, repairs or modifications at the device
serious health problems can be caused.
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Safety
1590 99 002_1 - 21. February 2011 5
2.2 Electrical hazards
WARNING
The laser is operated
with line voltage. There is the risk of an electrical shock! Do not open
the device, if you are neither trained nor authorized to do so.
The device is only to be operated with reliably grounded and perfectly installed sockets
with earthing contact.
WARNING
The laser is operated with line voltage. There is the risk of an electrical shock!
The device is designed to prevent the penetration of liquids during normal use.
If liquid
penetrates into the inner system space or the handpiece in exceptional cases,
you must
turn power off and pull the main power plug. Please contact our Technical Service.
2.3 Biological hazards
WARNING
The contact
There is the risk of microorganisms being transferred.
The selected handpiece 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-
compatibility according to EN 60601-1-2 is enclosed to this manual.
WARNING
Medical devices are subject to specific precaution measures concerning the
electromagnetic compatibility (EMC). The device emits low levels of electromagnetic
radiation that may have an effect on de
vices that do not comply with the standard.
Unintended settings at these devices could be the result of such an effect.
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 cellular phones and
similar equipment before putting the laser device into operation.
WARNING
The u
se of accessories and cables not authorized by the manufacturer may result in an
increased interference emission or a decreased immunity of the device with the above
mentioned consequences.
Use only accessories and cables that have been authorized by Ascl
epion Laser
Technologies for this result.
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Safety
6 1590 99 002_1 - 21. February 2011
WARNING
The device must not be stacked / arranged
close to or in combination with other devices. If
the device is operated close to or with other devices it must be checked if 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 less dangerous class 1).
WARNING
The device is a laser of class 4. That means that the
direct and even scattered laser
radiation can cause serious damage to the eye if the device is operated improperly.
The protection measures described in the following must be strictly observed.
It is of particular importance that all persons in t
he room in which the laser is operated put
on the appropriate eye protection during the active laser operation.
For fundamental rules on the handling of laser devices you are referred 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 to follow the rules specified below:
1. A laser protection officer should be appointed in writing who has at least the following
responsibilities:
monitoring of laser operation,
supporting the user on issues of safe operation and necessary protective measures,
cooperating with expert personnel on occupational safety in fulfilling their tasks,
including the information about important issues of laser radiation protection.
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 delimited and marked with a laser warning
sign. The laser area is the room in which the laser is used. Warning lights and a triangularly
shaped yellow laser warning label must be provided at all access points.
Figure 1: Laser warning label (European)
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Safety
1590 99 002_1 - 21. February 2011 7
3. The NOHD (Nominal Ocular Hazard Distance) of this laser system is very great so that the
entire laser session room is to be regarded the laser area.
4. Personal eye protection
WARNING
Laser radiation can cause serious damage to the eye.
Everyone present in the laser room during a treatment session must wear laser safety
goggles, the patients an eyeshield!
The laser safety goggles and the eyeshield for patients must compl
y 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 emission of laser radiation.
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 range 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 another area than the
intended one. Many surfaces, even the ones that seem to be mat, can strongly reflect
the emission wavelength of the laser.)
Point the active laser only onto the area that is intended for treatment.
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 phases of non-operation, you should switch to STANDBY mode (in the STANDBY
mode accidental release 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 releases the laser emission is responsible for the laser safety. He/she has to
ensure that all preventive measures have been taken before activating the laser. It is of
particular importance that all persons in the room, in which the laser is operated, including
the patients, put on the appropriate laser safety goggles or eyeshield.
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Safety
8 1590 99 002_1 - 21. February 2011
2.5.2 Laser-induced fire hazard
WARNING
Because of the laser radiation of 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 envirement which
is enriched with oxygen.
The Users shou
ld take the following precautions in order to prevent fires caused by laser
radiation:
Please expose only the proposed body areas to laser emission
Please use non flammable substances for the preparation of the treatment and for the
cleaning and disinfecti
on of the instruments directly before and during the treatment.
If it is not possible to avoid usage of solvents
such as alcohol or isopropyl alcohol
directly before and during the treatment, the vapour should be removed by aeration
before activation of the laser or at least wait for some time.
Please use non-flammable substances for anesthesia, if at all.
Avoid the use of oxidizing gases, e.g. nitrogen oxid (N2O) and
oxygen. Be especially
careful when using oxygen. Oxygen increases both the intensity and the extent of fire
.
Please keep a minimum of flammable materials in the treatment room only. If it is
necessary for the treatment to use flammable materials, please moisten these.
Keep clothes as far as possible away from the treatment zone.
Some materials,
which are saturated with oxygen (e.g. cotton), could be inflamed at
the high temperatures, which develop under the intended use of the laser.
Have always a small fire extinguisher and water ready in the treatment room
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Technical data
1590 99 002_1 - 21. February 2011 9
3Technical data
3.1 Device models
Designation Description
MeDioStar (NeXT)
(Part no. 1590) High power diode laser (main unit)
MeDioStar Handpiece
SDT
(Part no. 4020) Standard handpiece for hair removal
MeDioStar Handpiece HP
(Part no. 4022) High-power handpiece for hair removal
MeDioStar Handpiece
VAS
(Part no. 4021) Handpiece for vascular treatments
The standard delivery includes the main unit with one freely selectable handpiece.
The handpieces differ in their spectral emission characteristics of the diode modules used and in the
spot size.
3.2 Specifications
Specification MeDioStar
Device model Floor-based unit
Display
Operator guidance Touchscreen
Cooling Internal cooling cycle
Door interlock connector 5 V / 10 mA
Laser warning lamp Potential-free relay contact
max. 24 V / 1 A (make contact)
Permissible ambient
conditions
Temperature: 15 °C to 30 °C
rel. air humidity: max. 70 % (no condensation)
height: max. 2000m above sea level
Permissible transport and
storage conditions
Temperature: 0°C to +50°C
rel. air humidity: 10 % to 95 % (no condensation)
Dimensions 365 x 560 x 465 mm (W x D x H)
without handles and handpiece holder
Weight ca. 35 kg
Power requirements 100 -240VAC, 50/60 Hz, max. 1500 VA
Main fuse overcurrent release 16A, medium slow-blow
Overvoltage category II (IEC 60664-1)
Max. peak of mains voltage
Max. nominal mains voltage
V MT peak = 2500V peak
V MN r.m.s. = 300V r.m.s.
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Technical data
10 1590 99 002_1 - 21. February 2011
Classification according to
directive 93/42/EEC II b
Accessories see chapter Fehler! Verweisquelle konnte nicht gefunden w
e
r
-
den. Fehler! Verweisquelle konnte nicht gefunden werden.
Operating mode The device has been designed for continuous operation.
Specification MeDioStar
Laser model High-power diode laser array
Wavelength 800 - 950 nm (spectral distribution depends o
n the device
model; see chapter Fehler! Verweisquelle konnte nicht gefun
d
e
n
werden.)
Laser class 4
Required laser safety goggles
(acc. To DIN EN 207: 2009) 800 - 950 nm D LB5
Pulse duration max. 400 ms (depending on the mode and handpiece)
Pulse energy max. 60 J
Pulse frequency max. 12 Hz (depending on the mode and handpiece)
Spot sizes (handpieces)
handpiece STD: 14x10 mm²
handpiece HP: 8x6 mm²
handpiece VAS: 4x3 mm²
Tolerance of output power 20 %
Laser beam mode multimode
Laser beam diameter at the
handpiece output see spot sizes
max. 44 J/cm² @ handpiece STD: 14x10 mm²
Energy density max. 90 J/cm² @ handpiece HP: 8x6 mm²
max. 210 J/cm² @ handpiece VAS: 4x3 mm²
Beam divergence a
t the handpiece
output (round angle, 1/e2)
typ. 400 mrad @ handpiece STD
typ. 700 mrad @ handpiece HP
typ. 600 mrad @ handpiece VAS
Nominal ocular hazard distance
(with handpiece) 35 m
Protection class of the part used
B
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