© Copyright 2016 GME German Medical Engineering GmbH
GME LinScan
User Manual
GME LinScan Revision 14, dated 2016-06-08 Page 1 of 46
Legal Notice
Published by:
GME German Medical Engineering GmbH.
Headquarter: Grimmstr. 23, D-90491 Nuremberg, Germany
Operating site: Albert-Rupp-Str. 2, D-91052 Erlangen, Germany
Copyright © 2016 GME German Medical Engineering GmbH
These instructions, including all its parts, are protected by copyright. Any use outside the narrow limits
of copyright law without the consent of the GME German Medical Engineering GmbH is forbidden and
punishable. This applies in particular to duplications, translations, microfilming and storage and processing in electronic systems.
Like for any technical device, the medical devices of GME German Medical Engineering GmbH are
subject to ongoing developments. Even though the publisher has taken all possible care that the information contained in this manual is correct and corresponds to the knowledge at the release of the
manual, it is nevertheless subject to changes and errors.
Table of Contents
GME LinScan Revision 14, dated 2016-06-08 Page 2 of 46
Table of Contents
Legal Notice .............................................................................................................. 1
Table of Contents ..................................................................................................... 2
1. General Information.............................................................................................. 4
2. General Hazards and Safety Measures ............................................................... 5
2.1 Main Hazards and Measures ................................................................................................................. 5
2.2 Device Description and Security Concept ........................................................................................ 8
2.3 Eye Protection .......................................................................................................................................... 9
2.4 Patient Protection .................................................................................................................................. 10
3. Intended Use ....................................................................................................... 11
3.1 Intended Use ........................................................................................................................................... 11
3.2 Side effects and Complications ......................................................................................................... 11
3.3 Contraindications .................................................................................................................................. 11
4. Installation ........................................................................................................... 13
4.1 Scope of delivery and Unpacking ..................................................................................................... 13
4.2 Installation Requirements ................................................................................................................... 13
4.3 Installing and Connecting ................................................................................................................... 14
4.4 Initial start-up .......................................................................................................................................... 15
4.5 Functional Test ...................................................................................................................................... 16
5. Device Operation ................................................................................................ 19
5.1 Starting the device ................................................................................................................................ 19
5.2 Main Menu: Choice of treatment ........................................................................................................ 19
5.3 Setup Menu: Setting the System Parameters ................................................................................ 20
5.4 Treatment menu: Setting the treatment parameters .................................................................... 21
5.4.1 Setting the Clinical Parameters .................................................................................................. 21
5.4.2 Adjusting the treatment parameters ......................................................................................... 22
5.4.3 Setting the Technical Parameters .............................................................................................. 23
5.5 Scan Menu: Set the Scan Parameters .............................................................................................. 23
5.6 Laser Ready menu: Treatment ........................................................................................................... 24
5.7 Applicator handling ............................................................................................................................... 25
5.7.1 General operating instructions ................................................................................................... 25
5.7.2 Usage of the small spot adapter................................................................................................. 26
5.8 Menu Individual Parameters: Storage of Treatment Parameters .............................................. 28
5.9 Switching off ........................................................................................................................................... 29
6. Maintenance ........................................................................................................ 30
6.1 Cleaning of the base unit and the applicator ................................................................................. 30
6.2 Cleaning of the small spot adapter ................................................................................................... 30
6.3 Storage and Transport ......................................................................................................................... 30
6.4 Maintenance and Warranty ................................................................................................................. 31
Table of Contents
GME LinScan Revision 14, dated 2016-06-08 Page 3 of 46
6.5 Disposal ................................................................................................................................................... 32
6.6 Refilling cooling liquid ......................................................................................................................... 32
7. Specifications ..................................................................................................... 33
7.1 Specifications and Certification ........................................................................................................ 33
7.2 Device Labeling ...................................................................................................................................... 34
7.3 Electromagnetic compatibility (EMC) ............................................................................................... 36
7.4 System and Error Messages ............................................................................................................... 37
7.5 Accessories ............................................................................................................................................ 46
1. General Information
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1. General Information
This manual is directed exclusively to users who possess the necessary medical knowledge to operate the device in accordance with the legal requirements and have received training in device handling. All other persons are not permitted to use the equipment.
The instructions have to be observed in all dealings with the device. This includes transportation, unpacking, installation, medical application, maintenance, decommissioning and scrapping.
In the instructions you will find two types of advice for potential hazards:
1. Fields with the heading "Caution!" indicate hazards, which can damage the device (or possibly
other connected medical devices). Such damage can also be the loss of patient or system data. Precautions are proposed to avoid this damage.
2. Fields with the heading "Warning!" indicate hazards by which the patient, the user or third persons may be injured. Measures are proposed to minimize the risk of injury.
Example:
Caution! (Or Warning!)
Hazard: There is the hazard that ...
Action: Avoid ...
!
2. General Hazards and Safety
Measures
GME LinScan Revision 14, dated 2016-06-08 Page 5 of 46
2. General Hazards and Safety Measures
When using this medical device, the user has to take into account the general hazards described in
this chapter and observe the prescribed safety measures.
In addition to these general hazards there are additional risks that occur at various stages of use.
These are described in the chapters on these stages.
2.1 Main Hazards and Measures
Warning!
Hazard: The use of controls or settings or performance of proce-
dures other than those specified herein may result in the emission
of dangerous electromagnetic radiation.
Action: Follow the instructions in this manual exactly and do not
use any other controls.
Warning!
Hazard: Wireless communication devices, such as for example
mobile phones, portable phones or headsets can interfere with the
unit.
Action: Wireless communication devices have to be switched off
before starting treatment.
Warning!
Hazard: The device emits electromagnetic radiation. The effect on
cardiac pacemaker is not known. It cannot be excluded that this
radiation affects the proper functioning of the pacemaker.
Measure: Persons with pacemakers should not be present in the
treatment room during device operation.
Warning!
Hazard: The device emits electromagnetic radiation. The effect on
pregnant women is not known. Damage cannot be excluded.
Action: Pregnant women must not be present in the treatment
room during device operation.
Warning!
Hazard: Improper use may result in hazardous laser radiation be-
ing emitted uncontrolledly. This can lead to irreparable eye or skin
damage for persons present in the treatment room.
Action: The user manual has to be read completely by the user
before using the device. The instructions contained in this manual
have to be complied with.
!!!!!
2. General Hazards and Safety
Measures
GME LinScan Revision 14, dated 2016-06-08 Page 6 of 46
Warning!
Hazard: Improper use may damage the patient during treatment.
Action: The user must have the necessary and, where legally re-
quired, medical expertise and be fully trained on the use of this
device. Without medical expertise and instructions in the use of
the device, the device may not be operated.
Warning!
Hazard: When the device is operated by unauthorized persons,
the persons present in the treatment room may be irreparably
damaged.
Action: The device is secured entry against unauthorized use by
a PIN. This PIN protection implements the function of a key switch.
Therefore the user must not disclose the PIN to unauthorized persons, or note it on / near the device.
Warning!
Hazard: The high power density in the laser beam of the device
may ignite inflammatory substances, such as gases or liquids and
cause fire or explosions. Especially when working in the vicinity of
tubes or cavities of the body that contain flammable substances,
there is a fire and explosion hazard.
Action: The user must take precautions to avoid fire or explosion
hazard.
Warning!
Hazard: The technological and medical advances may mean that
the technology used and / or medical application may be outdated
and the benefit from the device might no longer outweigh the risks
after 10 years.
Action: The life time of the unit is limited to 10 years from the date
of first use. After this time, the intended use of the device has to
be re-evaluated by the manufacturer. Further use is permitted only
with a positive assessment.
Warning!
Hazard: The smoke or vapor generated by the laser light may
contain viable biological material such as viruses or bacteria.
Therefore there is a risk of transmission of diseases or infection.
Action: Use a mask and / or smoke evacuation during treatment.
!!!!!
2. General Hazards and Safety
Measures
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Warning!
Hazard: The unit is connected to the mains. The mains voltages
can cause an electric shock upon touching the device if the device
does not work properly or is damaged. This can lead to injury or
even death.
Action: Check that the device and especially the cables are in an
undamaged condition before switching on.
Warning!
Hazard: The unit is connected to the mains. The mains voltages
can cause an electric shock upon touching the device if the device
does not work properly or is damaged. This can lead to injury or
even death.
Action: Check that you have purchased the product from GME or
an approved GME distributor before switching on. Do not switch
the unit on if you cannot exclude that an unauthorized manipulation to the device has been done or that it has been opened by an
unauthorized person.
This device may not be modified without the permission of the
manufacturer. If the unit has been modified, appropriate examinations and tests have to be are carried out in order to ensure safe
use.
Warning!
Hazard: The unit is connected to the mains. The mains voltages
can cause an electric shock upon touching the device if the device
does not work properly or is damaged. This can lead to injury or
even death.
Action: Maintenance and repair works on the device may only be
performed by GME or an authorized GME distributor.
Warning!
Hazard: The unit is a Class I electrical medical device. It must
therefore be connected with protective earth conductor to a utility
grid. The voltages applied here can otherwise cause injuries or
death due to an electrical shock upon touching if the device is
damaged or not working properly.
Action: Warning! To avoid the risk of electric shock, this unit must
be connected to a power supply line using a protective earth conductor.
!!!
!
2. General Hazards and Safety
Measures
GME LinScan Revision 14, dated 2016-06-08 Page 8 of 46
Warning!
Hazard: The device is an electrical product with integrated liquid-
cooling circuit. In the case of a liquid leakage with liquid covering
electronic components of the device, there is the risk of device
malfunctions and electric shock. This electric shock could cause
injuries and even death.
Action: Attention! Before switching on the device check if there is
cooling liquid close to, under, or at the device. In order to avoid the
risk of an electric shock the device may only be switched on if the
test showed no visible liquid. In case of a leakage during device
operation, switch off the device immediately by using the main
switch on the left side of the housing.
2.2 Device Description and Security Concept
The device LinScan consists of a base unit and an applicator. Both are connected by a hose.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, the door plug and USB devices are connected there. The touch-screen serves as the main control panel.
Warning!
Hazard: If the touch-screen is defective, damaged, poorly legible
or filthy this may lead to incorrect treatment settings. In this way
the patient may be injured.
Action: Do not use the unit with a defective, damaged, poorly legible or filthy touch-screen. If necessary, clean the touch-screen or
call service to have a repair / maintenance performed.
The applicator directs the laser light along an optical path to a scanning device for deflecting the laser
beam. The applicator is hand-held by the user and placed onto the skin. It has a hand switch on the
front of the handle.
During development and manufacturing applicable directives, legal requirements and standards for
medical devices were considered. Your product complies to them.
If you turn on the device, then the unit performs several tests automatically. Thereby the proper functioning of the device - according to the specifications - is ensured. As soon as these tests have been
completed successfully, the device is ready for parameter selection and patient treatment. In addition
to the initial tests a number of device functions and parameters are monitored continuously.
If the unit detects abnormalities or defects, then it reacts depending on the nature and importance by a
notice, a warning or error message. This message needs to be confirmed by the user. Depending on
the message one of the following cases is possible:
the user needs to perform an action to eliminate the cause of the message (Example: The us-
er has to take his foot off the foot switch or order a device service)
the user must wait for a change of parameters (Example: the temperature of the device is too
low, the user must wait until the unit has warmed up sufficiently.)
the device attempts to resolve the cause of the error and performs a re-test (Example: a too
high / low laser power was measured. The device performs an adjustment of power. )
A reboot of the device is required. The device switches off automatically.
!
!
2. General Hazards and Safety
Measures
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Caution!
Hazard: Not observing device messages may result in damage or
malfunction of the device.
Action: Make sure you follow the instructions that are displayed
by your device.
Warning!
Hazard: Not observing device messages may result in device mal-
function and injury to patients, users or other persons present in
the treatment room.
Action: Make sure you follow the instructions that are displayed
by your device.
2.3 Eye Protection
The device LinScan emits laser radiation in both the visible (target beam) and invisible regime. This
radiation can damage the eyes of all persons present in the treatment room. Therefore, all people in
the room have to wear eye protection. The user and any other people in the room except the patient
must wear protective eyewear that meets the specifications below. For patients, there is a choice between protective goggles or ocular shield.
The LinScan is a class 4 laser, i.e., it may cause damage eyes and skin. At the laser wavelength of
808nm or 980nm the laser radiation has the following characteristic values:
The maximum permissible exposure (MPE) is 16 W / m ²
The safety distance for damage to the eyes (NOHD) is 4.36 km.
The minimum optical density (OD) of the eye protection goggles for all persons within the
safety distance is 6
The standard EN 207 defines the classification of protective eyewear. The protective eyewear used for
the LinScan 808 must carry at least the following markings:
D 808 LB 6
The protective eyewear used for the LinScan 980 must carry at least the following markings:
D 980 LB 6
This means:
Operating Mode D (= CW emission) and I (=pulsed emission)
Wavelength 808nm or 980nm (it is also possible that a wavelength interval is specified which
includes 808nm or 980nm, such as e.g. 800-1000)
Protective Level LB 6 (a higher level of protection may also be selected)
Warning!
Hazard: The laser light may damage the eyes of all people in the
room even by only indirect irradiation or diffuse reflection beyond
repair and result in blindness.
Action: All people in the room must wear eye protection that
meets the requirements defined above. Make sure of eye protection that is undamaged and in perfect condition before each use.
Never look directly into the laser beam even with eye protection.
!!!
2. General Hazards and Safety
Measures
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2.4 Patient Protection
Due to the treatment the patient is subject to hazards which are described below and can be minimized by the measures described.
To protect the patients against allergic or toxic reactions and irritation from contact with parts,
only accessory parts authorized by GME may be used. Only for these parts biocompatibility is
ensured.
Infectious biological material can be transmitted by not properly disinfected parts which con-
tact the patient. Disinfect any parts that touch the patient after each patient!
To protect the eyes, protective measures in accordance with Section 2.3 have to be taken.
Substances applied to the skin of the patient, such as creams, ointments, perfumes, or ingest-
ed photosensitizing drugs can alter the interaction of the incident light with the skin. This might
cause injury to the skin of the patient. Therefore, the ingestion of such drugs should be asked
for by the practitioner before the treatment. If the patient has taken such drugs he/she should
not be treated. Similarly, the treatment zones have to be cleaned of all applied substances before treatment.
The use of accessories not authorized by the manufacturer can lead both to a change in the
clinical effect as well as to a change in the actual treatment parameters. Therefore, only accessories authorized by GME may be used. This stays valid even if the manufacturer of the
accessory issued a release document or a test laboratory states the innocuousness.
3. Intended Use
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3. Intended Use
The device LinScan is a diode laser (808nm or 980nm) with scanner for dermatological treatments.
Upon impingement of the laser radiation on the skin, the infrared light is mainly absorbed by the melanin and hemoglobin in the skin. Skin structures containing melanin and hemoglobin, like e.g. hair,
pigmented lesions, blood vessels are thus heated more strongly than the surrounding tissue. These
structures are thus damaged irreversibly or are coagulated.
3.1 Intended Use
The intended use of the device LinScan is:
Permanent hair removal
Vascular lesions including angiomas, hemangiomas, telangiectasia, leg veins
Pigmented lesions
Pseudofolliculitis barbae
Onychomycosis
3.2 Side effects and Complications
The following side effects and complications have been reported in treatments with the same or similar
intended use in the literature and can therefore occur also in treatments with the LinScan:
a) For all indications
Erythema
Blister formation
Edema
Pigmented lesions (lentigines) and freckles may bleach or disappear
Light Pain
Postinflammatory hyperpigmentation
Hypopigmentation
Scarring
Herpes simplex
Purpura
Hyperhidrosis (increased sweating)
Bromhidrosis (strong smell and excessive sweating)
Leukotrichia (White hair)
b) In addition to a) for the indication onychomycosis
Hematomas
Nail deformities
Nail discoloration
Onycholysis
3.3 Contraindications
For treatment with the LinScan the following contraindications exist:
a) For all indications:
Long healing periods after preceding treatments
Tanned skin
Known keloid formation or anormal scar formation
Predisposition for hypo- or hyperpigmentation
Isotretinoin medication
Photosensitizing medication like tetracylines or retinoids
Hydroquinone or other bleaching agents
3. Intended Use
GME LinScan Revision 14, dated 2016-06-08 Page 12 of 46
Known herpes infection in treatment area
Tattoo in treatment area
Pregnancy
b) In addition to a) for the indication hair removal:
Use of other hair removal devices or other hair removal methods like e.g., waxing, hair pluck-
ing, or hair removal by electrolysis during the preceding 6 weeks
c) In addition to a) for the indication vascular:
Blood coagulation disorders
Anti-coagulation medication
Presence of varices that are feeding telangiectasias
d) In addition to a) for the indication pigments:
Blood coagulation disorders
Personal or family history of melanoma
Dysplastic nevi
Lack of ability or will to obey physician’s orders
e) In addition to a) for the indication onychomycosis
polyneuropathy
scleroderma
psoriasis of the skin and / or nails
circulatory disorders
These contraindications must be asked for by the user during anamneses in order to avoid later complications.
The user should take steps to herpes prophylaxis prior to treatment if a relevant medical history exists.
4. Installation
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4. Installation
4.1 Scope of delivery and Unpacking
The unit is supplied in a special carrying case, which in turn is put into an outer package for transportation by mail or parcel service. Upon delivery, please remove the carrying case and any accessories
from the outer packaging. Please open the carrying case carefully so that no parts can fall out.
Please check that all parts – according to the delivery note - are actually included and undamaged. A
complete delivery - ordered without any additional optional accessories - includes the following components:
Base unit with an attached applicator
User manual (this document)
Quick Treatment Guide
Packaging Instruction
Power cord
Foot switch with connecting cable
One pair of laser protective goggles
Applicator holder
Refill kit
Upon damaged or missing parts, please immediately contact the manufacturer or distributor. Do not
use the device under any circumstances!
If all parts are contained place the base unit with the applicator on a stable surface. Follow the installation requirements specified in the following chapter.
Keep the outer packaging and packing materials. The carrying case and outer packaging may be required for the transport or shipping of the device. Do not ship or transport the device without the appropriate box!
Caution!
Hazard: The transport or shipping of the device without appropri-
ate packaging may damage the device and thus lead to a malfunction of the device.
Action: Transport or ship the device only in transport cases and
packaging cleared by the manufacturer. If you do not have such
case or such packaging, please contact the manufacturer or your
dealer. He will provide you with suitable means of transport.
4.2 Installation Requirements
Before installing this equipment, users must make sure that the following requirements are fulfilled at
the intended treatment room. In addition, the user has to comply with all legal requirements, which are
valid at the location of use.
Required installation location: The device should be placed on a table. It must not be placed
directly against a wall, neither on the left nor right side, otherwise the ventilation is blocked.
On both sides, a distance of 50 cm to the next surface is required.
Separation from other electrical devices: The equipment must not be placed directly above,
below or next to other electrical devices. Excluded are devices or accessories that are specifically provided by GME for such an assembly or have been released for this purpose by
GME.
Electrical connection: The appliance should be plugged into an outlet with its own fuse pro-
tection. It must not be connected to multi-outlet power strips or other distribution outlets. An
appropriate power cord with a protective earth is provided by the manufacturer.
!
4. Installation
GME LinScan Revision 14, dated 2016-06-08 Page 14 of 46
Electric power supply: The electric power supply must be within the specification of the tech-
nical data, see Chapter 7.1. The quality of the supply voltage should correspond to the quality
of a typical commercial or hospital environment.
In order to prevent damage by electrostatic discharge, the floor in the treatment room should
be made of concrete, wood or tiles. When using synthetic materials, the relative humidity has
to be above 30%.
The treatment room must meet the requirements for laser safety according to EN 60825-1.
Especially, it must be equipped with laser warning signs, as shown below, which have to be
placed at all entrances to the treatment room at eye level. In addition, a laser warning light
must be available at all entrances. The room itself must not contain reflecting surfaces, such
as mirrors.
Room temperature and humidity: The device may only be operated within the acceptable tem-
perature and humidity range in accordance with the technical data, see chapter 7.1.
Heat dissipation: The unit produces heat due to technical reasons. This can lead to a signifi-
cant warming of the treatment room and to a rise of temperature above the maximum permissible ambient temperature for device operation. To ensure continuous operation and to keep
the room temperature for users and patients as comfortable as possible, we recommend aircondition of the treatment room. An air-conditioner with a maximum cooling power> 1000W
should be used.
Renovations: Renovation work in the treatment room must be completed at least 1 week prior
to installation of the device. Otherwise, dust or paint fumes may deposit on optical elements
cause damage to them.
4.3 Installing and Connecting
Lift the base unit with an attached applicator from the carrying case and put it in a suitable place (according to the installation requirements in the previous section).
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