GME LinScan 808 User Manual

© 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

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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

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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

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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

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 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).

4. Installation

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Figure 1: LinScan base unit, applicator and applicator holder

Make sure that the applicator is not detached from the holder and does not fall to the ground!

Connect the foot switch on the left side of the base unit. Make sure that the connector locks into place
completely. Then connect the base unit to the power socket using the supplied power cord. The de­vice-side connector is also located on the left side of the base unit. The power connector and the
socket must meet the "Installation Requirements" described above.

If you want to use a remote door interlock remove the protective cap of the jack on the left side of the
device. Connect the two cables of the remote interlock to the plug of the device terminals. While con­nected to the plug, the device only allows the emission of laser light when the door is closed and thus
the remote door interlock contact is closed. If the door is opened, laser emission is stopped.

Double check that all parts are connected correctly and securely and that they are not damaged. Use
the device only if this is the case.

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.

4.4 Initial start-up

Put on laser protective eyewear that meets the requirements of the chapter "Eye protection".

!

4. Installation

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Unlock the red emergency stop button on the top of the base unit by turning the button. Otherwise the
device cannot be switched on. Then use the power switch on the left side of the device to turn on the
device. On the front panel you now see the blue/red (depending on the device version) light of a LED
below the Power-on symbol in the middle. Press this symbol and hold it pressed for one second. The
LED turns green and the boot process of the device starts.

Figure 2: Left side of base unit with power switch and connectors for foot switch, mains cable, door inter­lock, and USB memory stick

After a short time, an input screen is displayed, which prompts you to enter a PIN. This PIN can be ob­tained from the person doing the initial training on the use of the device.

After entering the PIN the device displays the main menu. Proceed as described in the following chap­ter "Function Test" to check that the device is functioning properly in accordance with the intended
use.

4.5 Functional Test

The function test has to be performed during the initial installation and after every change of location
to ensure proper function.

Warning!

Hazard: The functional test verifies that the device works as in-

tended. If it is not performed during initial start-up or after change
of location, the proper working according to the intended use is not
guaranteed. Injury of patients or users cannot be excluded in this
case.

Action: Perform the functional test at initial start-up at a site and
after each change of location.

!

4. Installation

GME LinScan Revision 14, dated 2016-06-08 Page 17 of 46

For functional testing, you will need the device, a microscope slide, and a grey or grey-printed piece of
paper or, alternatively, a cardboard.

Press the left button "Hair removal" located on the top left. The screen now changes to the screen
for selecting the treatment parameters, called the treatment menu. The screen should look like the fol­lowing:

If you see other parameter settings as given in the above image, change the settings, please see the
section "Treatment menu" to set the values.

Place the microscope slide on the cardboard or grey paper. Then press the "Laser Start" button and
set the sapphire crystal vertically onto the slide.

After a short time, the red aiming beam should be visible, showing the outer contours of the treatment
area. The aiming beam moves through the same optical system as the working beam. Therefore, the
aiming beam offers a suitable means of verifying the integrity of the optical system. If the target beam
is not present at the distal end of the optical system, its intensity is reduced, it can be seen only dif­fusely or the shape is distorted, it is a sign of damaged or faulty optical system. Stop the function test
in this case and contact the manufacturer or distributor.

If the aiming beam shows the defined rectangle, press the foot switch with your foot and hold it down
until the device has covered the full rectangle. Then take your foot off the foot switch.

Make sure that the burned area is uniform and the outer limits of the square coincide with the rectan­gle shown by the aiming beam. Do not use the device if the pattern is uneven, if no 50mm x 15mm
rectangle was scanned or if the individual areas are darker than others. Stop the function test in this
case and contact the manufacturer or distributor.

4. Installation

GME LinScan Revision 14, dated 2016-06-08 Page 18 of 46

Warning!

Hazard: The occurrence of errors during the functional test indi-

cates damage to the device. A proper function is no longer guar­anteed. Patients or users could be injured by using the damaged
unit.

Action: Stop use of the device immediately if errors occur during
the functional test. Turn the unit off and contact the manufacturer
or your dealer.

!

5. Device Operation

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5. Device Operation

This chapter describes the operation during normal use, as it was valid at the time of printing this
manual. Due to technical changes and software updates the handling may change. If you find discrep­ancies, please contact the manufacturer or distributor. He will send you the latest version of this man­ual.

5.1 Starting the device

Put on laser protective eyewear that meets the requirements of the chapter "Eye Protection".

Then use the power switch on the left side of the device to turn on the device. On the front panel you
now see the blue/red (depending on the device version) light of a LED below the Power-on symbol in
the middle. Press this symbol and hold it pressed for one second. The LED turns green and the boot
process of the device starts.

After a short time, an input screen is displayed, which prompts you to enter a PIN. This PIN can be ob­tained from the person doing the initial training on the use of the device or you can define your own
PIN. In chapter “Setup menu” this is described.

After entering the correct PIN the device displays the main menu. If you entered the PIN incorrectly
three times in a row, the device will be blocked for one hour. Renewed attempts to enter PIN are only
possible after this time again.

If errors occur during self-test a message will be displayed. The device might also ask you to perform
an appropriate action. Follow the instructions!

5.2 Main Menu: Choice of treatment

The main menu shows several buttons arranged in rows and columns. The middle display zone –
highlighted by the light gray background - contains all the keys you need for performing a treatment.
The bottom row contains the “Settings” button, which provides access to device-specific settings, see
the chapter "Setup Menu".

Press one of the slightly larger buttons of the first column to enter the treatment menu (see "Treatment
Menu"). No indication-specific parameter recommendations are provided in this case. This option is
therefore suitable for experienced users and experts who have already gained clinical experience with
this or similar systems and who know the appropriate treatment parameters.

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 20 of 46

By selecting one of the slightly smaller buttons of the following columns you can also access to the
treatment menu (see "Treatment Menu"). However, in this case the device recommends appropriate
treatment parameters for a specific indication. This wizard system is particularly suitable for beginners
and other users who are not experienced in treating with the device. It is possible to change the pro­posed parameters in the treatment menu itself also in this case.

If you select one of the buttons in the last column, you enter the menu "Custom Parameters". Here,
you can save or load your preferred individual treatment parameters.

5.3 Setup Menu: Setting the System Parameters

In this menu you can change the following system settings to suit your needs:

 The date and time can be set. Press the labeled button and perform the changes in the result-

ing window.

 You can select the language. Once you press the arrow button on the right side of the lan-

guage box, you get a list of available languages. Select the desired language.

 You can choose to start laser emission using the foot or hand switch by pressing the appropri-

ate button.

 Pressing the button "System Data" opens a window in which you receive basic information

about the device status. These include the serial number of your device, information about the
last service, operating hours, temperature information and the software version information.

 Pressing the button "Applicator Settings" opens a window where you can see applicator-

specific data and set applicator-specific parameters.

 The section "Volume" allows you to specify how loud notification beeps such as the confirma-

tion of a pressed button are heard. However, this setting does not change the volume of warn­ing signals because of legal reasons.

 The button "Service" is only relevant for service technicians. It leads to a PIN-protected menu.

Never try to guess the service PIN of the device or do changes in the service menu settings.
This could either damage the device or lead to hazards for users and / or patients.

 Pressing the "Software Update" button allows you to update the software on your device by

yourself. If you want to perform a software update, then plug the storage device (e.g. an USB
memory stick or USB hard drive) into the USB port of the device. Press the "Software Update"
button. The unit will now recognize the storage medium automatically and display the software
versions thereon. Likewise, the currently installed software versions are displayed on the de­vice. Select the software version that you want to install and start the installation. The unit will
guide you through the installation process and gives you instructions. Follow the instructions in
any case and do not turn the power off during the update process! In general, a device reboot
is necessary when the installation is complete.

 Under "Error List" you will find information about the error and warning messages that the de-

vice has generated in recent times. This information is usually required by a technician to de­termine the cause of equipment failure. The error list can be transferred to a USB storage de­vice and then be transmitted by email to the manufacturer or distributor.

 Under “Master License” and “User License” you are able to check the license status of the de-

vice. Here you are able to create a new key for receiving a new license if necessary.

 Under “User PIN” you are able to define your own PIN. The PIN has to consist of 5 numbers.

Caution!

Hazard: Turning off the device during a software update or cancel-

ing the software update may cause the device to remain in an in­operative state so that it cannot be used further.
Action: Never interrupt a software update. Always obey the in­structions given by the device during the update process.

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5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 21 of 46

Caution!

Hazard: Storage media may contain malicious software such as

computer viruses, Trojan horses or computer worms that can af­fect the operation of this unit.
Action: Check the storage medium that you want to use for the
software installation, with an up-to-date virus scanner for malicious
software before you connect it to the device. Never use the media,
if malicious software has been found.

5.4 Treatment menu: Setting the treatment parameters

The treatment menu shows a tripartite division. The top row contains information about your selected
clinical indications and relevant clinical parameters. In the middle you see the most important treat­ment parameters of the laser and can change them. In the bottom line, technical parameters such as
selected scan field can be viewed and modified.

5.4.1 Setting the Clinical Parameters

In the top row of the treatment menu you see an icon of the indication that you selected on the main
menu. In addition, depending on the indications, more buttons appear. In the shown example, these
are the skin type, the hair thickness, and the hair color. Press the "Accept" button to confirm the selec­tion.

According to your selection the device recommends an appropriate set of treatment parameters.

The treatment parameters proposed by the device are merely a non-binding recommendation. Be­cause of the complexity and numerous factors that can influence these recommendations not all clini­cal relevant facts can be included. Specifically consider contraindications, susceptibility to side effects,
medical history, current health situation, etc. The user must not rely on the correctness of the recom­mendations, otherwise the patient may be harmed. The user must take into account all clinically rele­vant facts that are known via the medical history or clinical case in the selection of treatment parame­ters before any treatment. With these treatment parameters the user must perform a test treatment on
one location. Wait for the patient's response to this test treatment before performing further treatment.

!

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 22 of 46

5.4.2 Adjusting the treatment parameters

The middle area of the treatment menu allows adjustment of the relevant treatment parameters. Use
the slider to adjust - depending on the application - the fluence or energy density, pulse duration, and
skin cooling temperature.

If you have entered the treatment menu via an indication-based button, the pointer of each slider rep­resents a recommended value. In addition, a light-background zone denotes a recommended parame­ter regime for the selected indication.

For some sliders, there might be a red parameter zone that is secured with a lock. Parameters in the
red zone are potentially dangerous and might harm the patient. They should be used only for carefully
selected, specific treatments. The use of this parameter regime is not recommended by the manufac­turer. If you still want to use these parameters, you must first unlock the red zone by touching the lock.
Only after that you can move the slider into the red zone.

Warning!

Hazard: The unit allows you to treat even with aggressive treat-

ment parameters that are appropriate only in special cases. If
these parameters are used for other indications, the patient may
be injured permanently or temporarily.

Action: Only use aggressive treatment parameters with adequate
experience and for indications that do not allow more conservative
parameters. Do a test treatment on a small area to ensure that no
adverse side effects or unacceptable damage will be caused by
the treatment. Wait for the patient's response to the test treatment.
Stop treatment immediately if unwanted side effects occur.

Please note that the device generates the recommended parameter sets as a result of your entered
data and without knowledge of the actual patient history. It is your responsibility as a physician to take
into account all other patient data according to medical history, contraindications, clinical findings or
other knowledge.

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5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 23 of 46

Warning!

Hazard: The treatment parameters proposed by the device are

merely a non-binding recommendation. Because of the complexity
and numerous factors that can influence these recommendations
not all clinical relevant facts can be included. Specifically consider
contraindications, susceptibility to side effects, medical history,
current health situation, etc. The user must not rely on the correct­ness of the recommendations, otherwise the patient may be
harmed.

Action: The user must take into account all clinically relevant facts
that are known via the medical history or clinical case in the selec­tion of treatment parameters before any treatment. With these
treatment parameters the user must perform a test treatment on
one location. Wait for the patient's response to this test treatment
before performing further treatment.

On the left side of the slide you see the selected treatment parameters as a number value in SI units.

As soon as you have set all the parameters, confirm your selection by pressing the "Laser Start" but­ton. The device enters the “Laser Ready Menu”, which is described in the relevant section.

5.4.3 Setting the Technical Parameters

The bottom row on the treatment menu includes navigation buttons as well as information and settings
for technical parameters.

The navigation elements are arranged in the outer left and right buttons. Pressing the "Back" button al­lows you to access the main menu. The "Settings" button leads to the "Setup Menu" and pressing the
"Save" allows you to save individual parameters.

In the field "Total energy", the emitted laser energy since the last reset is displayed. Pressing the "Re­set" button sets this counter to zero.

The remaining 3 buttons indicate the selected parameters for the scan pattern, namely its size, the
scan mode, and the repositioning break. Press one of the 3 buttons, to enter the "Scan menu", which
is described in the following chapter.

5.5 Scan Menu: Set the Scan Parameters

In the Scan menu, you can set the following parameters of the scan pattern on the skin:

 Scan Area Size: In the uppermost line you will find the possible choices of scan area size. Se-

lect your preferred size by pressing the corresponding button. By pressing the button “Adapt­er” you can activate or deactivate the settings for using the small spot adapter.

 Scan mode: In the second line you can choose in how many parts the scan area should be di-

vided in order to reduce pain. Choosing the first setting “One area” causes the whole treat-
ment area to be scanned in one go, i.e., without any pause. Choosing the “Four area” setting

will cause the treatment area to be divided into four areas which are treated temporarily sepa­rated. This leads to a significantly reduced patient pain level. The desired mode is selected by
pressing the corresponding button.

 Scan break: In the third line the buttons to select the duration of the repositioning scan break,

i.e., the pause between two laser pulses in case the user keeps the selected switch pressed.

During this break the user has to move the applicator to the next treatment position. If “Manu-
al” has been selected the device will not emit a second laser pulse. In this case the user has

to release the switch and press it again in order to treat the next location. The desired mode
is selected by pressing the corresponding button.

 Subpulses: In the last line the number of subpulses is selected. This line is only visible in MCT

hair removal mode. In this mode each area is treated more than once. The desired number (1-

!

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 24 of 46

4) can be selected by the user. Be aware that the treatment menu always displays the total
fluence, i.e. the fluence of each pass is only a uniform fraction of the total fluence.

5.6 Laser Ready menu: Treatment

To start a treatment and trigger laser pulses press the "Laser Start" button on the treatment menu
screen, as described in chapter "Treatment menu". When changing from/to adapter mode the device
is asking you if you have removed/attached the adapter.

Place the applicator on the skin.

The screen changes and the aiming beam moves along the external boundaries of the area to be
treated on the skin. The screen shows your selected treatment parameters. These cannot be changed
in the laser ready menu.

The treatment, i.e., emission of laser pulses, starts when you press the hand or foot switch. It stops as
soon as

- the selected skin area was treated completely

- the hand or foot switch is released

- the door contact is open

- the "STOP" button on the screen is pressed

- the selected skin cooling temperature cannot be maintained any longer

- an error occurs

During the emission of laser pulses, an acoustic warning signal is heard. In addition, an indicator LED
on the applicator signals the emission optically.

When you release the hand or foot switch or the door contact is opened, while the selected skin area
has not been fully treated, the treatment is continued at the next treatment position, when you press
the hand or foot switch again. This, however, is not the case, if you press the "STOP" button.

As long as you are in the laser ready menu, you cannot change treatment parameters on the screen.
Press the "STOP" button on the screen to stop the laser emission and / or return to the treatment
menu. No laser pulses can be triggered any more.

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 25 of 46

5.7 Applicator handling

5.7.1 General operating instructions

On the front side of the applicator there is a hand switch. Laser pulses can be triggered by pressing
this switch if the hand switch has been activated in the setup menu. Please note that the operator has
to hold the handle of the applicator tightly in order to start laser emission. The applicator is equipped
with a heel-of-hand detection to avoid unintended laser emission!

Figure 3: LinScan applicator with hand switch and sapphire crystal

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 26 of 46

When not in use place the applicator on the applicator holder to prevent it from falling down or being
damaged by other sharp items.

Caution!

Hazard: The applicator may fall down or be damaged by sharp

items/ edges when not placed on the appropriate applicator holder
while not in use.
Action: Always place the applicator on the applicator holder when
not using it.

5.7.2 Usage of the small spot adapter

To use the small spot adapter you have to fix it to the sapphire crystal. Put the applicator into the ap­plicator holder as shown in figure 4.

Figure 4: Position of the applicator for installing the small spot adapter

!

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 27 of 46

Mount the small spot adapter on the sapphire crystal so that the screw points in the direction of the
applicator handle (Figure 5). Please ensure that the adapter flatly touches the colored elastomer.

Figure 5: Small spot adapter mounted on the sapphire crystal

Use two fingers to press down the small spot adapter while tightening the screw (Figure 6).

Figure 6: Fixing the small spot adapter

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 28 of 46

Figure 7: Schematic drawing –fixing the small spot adapter

Remove the adapter from the sapphire crystal after you finished treatment and deactivate the adapter
mode in the scan menu by choosing another scan area size.

Caution!

Hazard: If the adaptor is not attached and the software is in the
adaptor mode, a higher fluency will be delivered.
Action: Attach adaptor then select adaptor mode in software. De-

select adaptor mode when adaptor is removed.

Caution!

Hazard: There will be no laser emission if the adapter is fixed in
the wrong direction to the sapphire crystal.
Action: Please check whether the screw of the adapter points in

the direction of the applicator handle before using the small spot
adapter.

5.8 Menu Individual Parameters: Storage of Treatment Parameters

To save the last set of your treatment parameters, press the "Save" button on the treatment screen.
Pressing this button takes you to the "Individual Parameters" menu. Here you can save the data using
a name of your own choice or load already stored parameters.

To enter the menu “Individual Parameters” directly press the button “Stored settings” in main menu.

By pressing the button of a previously stored parameter set you enter the treatment menu. The stored
parameters are now already set. By confirming with the "Laser Start" button you can directly start the
treatment with this set of parameters.

!

!

5. Device Operation

GME LinScan Revision 14, dated 2016-06-08 Page 29 of 46

5.9 Switching off

To switch the device off, press the On /Off button in the middle of the front panel of the device. Wait
until the LED color changes from green to blue/red (depending on the device version). Then you can
turn off the power completely at the main switch on the left side of the device.

In an emergency, the unit can be switched off be pressing the red emergency stop button on the top of
the base unit. Any laser emission is stopped immediately. The LED on the front panel turns to
white/red (depending on the device version). If the button has been pressed, it must first be unlocked
by turning the button. Otherwise the device cannot be switched on again.

Always switch off the power using the main switch before performing cleaning or maintenance work or
before moving the unit.

6. Maintenance

GME LinScan Revision 14, dated 2016-06-08 Page 30 of 46

6. Maintenance

6.1 Cleaning of the base unit and the applicator

Before cleaning, always unplug the device completely from the mains. For this purpose unplug the
power supply cord from the outlet. The surfaces of the device should be cleaned at regular intervals
using a cleaning agent suited for PMMA (acrylic glass), e.g., dish liquid mixed with water. For severe,
fat-containing stains you can also use pure benzene-free gasoline (benzine, light benzine). Never use
cleaning agents that contain abrasive materials.

If disinfection is required, please use a spray or wipe disinfectant that is suited for acrylic glass (or
PMMA) and displays. Examples are “Hexawol” produced by the company Dreiturm or Kohrsolin extra
produced by the company Hartmann. When using other disinfectants, the front of the device or the
display may be damaged.

The applicator and its sapphire crystal should be disinfected using the above mentioned disinfectants.
Applicator cleaning can be done using the cleaning agents defined above.

Please check whether the sapphire crystal is free from contamination before turning on the device. If
you find dirt on the sapphire crystal, then clean it using the disinfectants defined above. Never perform
this crystal cleaning action when the unit is switched on.

Warning!

Hazard: In case of an accidental triggering of laser pulses during

the cleaning process of the sapphire crystal, the eyes or skin of
the cleaning person could be harmed.

Action: Do not perform sapphire crystal cleaning with the unit
switched on. Turn off the power before any equipment cleaning
and always unplug the power cord from the wall outlet.

Caution!

Hazard: The penetration of larger quantities of liquid into the de-

vice can damage the unit. This is also true for water.

Action: Only perform any cleaning actions with wipes lightly
dampened with cleaning agents. Do not use wet wipes. Do not
pour any liquids on the device. Avoid penetration of liquids into the
unit.

6.2 Cleaning of the small spot adapter

The adapter should be cleaned after each usage. Please use a suited cleaning or disinfectant agent,
as the ones mentioned in chapter 6.1.

6.3 Storage and Transport

The device is a high quality electric device with optical elements. When not in use, the device should
be stored in the included carrying case, but in any case protected against dust and moisture.

The transport of the equipment should be performed only in the supplied carrying case. Should the
unit be shipped, then the carrying case has to be put in the outer packaging specified by the manufac­turer.

You should therefore keep the case and on the outer packaging. Case and packaging are always re­quired for the transport or shipment of the unit. Never ship or transport the device without the appro­priate packaging!

!

!

6. Maintenance

GME LinScan Revision 14, dated 2016-06-08 Page 31 of 46

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 unit in packaging specified by the
manufacturer. If there is no such packaging, please contact the
manufacturer or your distributor. He will provide you with suitable
means of transport.

6.4 Maintenance and Warranty

The device comes with various sensors and wear counters. Should they detect the need for mainte­nance, you will receive a user a notification by the device. After confirmation of the notice you can con­tinue working. Please immediately contact the manufacturer or his authorized distributor.

Should the device detect critical wear which does not guarantee safe working any more or could lead
to more damage to the device, you will also get a notification by the device. However, it is no longer
possible to continue work in this case. Please immediately contact the manufacturer or his authorized
distributor.

Regardless of the actual use at least once per year an inspection and service of the equipment is
compulsory. Please contact the manufacturer or his authorized distributor in time.

Caution!

Hazard: The maintenance and repair of the equipment requires a

detailed knowledge of the device. Without this knowledge, the de­vice may be damaged during maintenance or repair. Moreover, a
proper function is no longer guaranteed in this case.

Action: Any maintenance or repair work may only be done by the
manufacturer or an authorized person. Never let any unauthorized
persons perform such work.

Warranty is granted in accordance with the conditions set out in purchase contract and the respective
national laws. Single-use parts, wear parts, and consumables are excluded from this warranty. In addi­tion, it voids the warranty, if

 maintenance or repair was conducted by unauthorized persons.
 the device was opened by unauthorized persons.
 the installation requirements were not met.
 the device was not used in accordance with the instructions contained in this user manual.
 the device was used in combination with accessories or other equipment not authorized by the

manufacturer.

For any warranty claim, please contact the manufacturer or your local distributor immediately.

!

!

6. Maintenance

GME LinScan Revision 14, dated 2016-06-08 Page 32 of 46

6.5 Disposal

Warning!

Hazard: The technological and medical advances may mean that

the technology used and / or medical application will be outdated
and no longer the benefit from the device might 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.

The device must not be disposed of as waste or household waste. It falls under the provisions of EU
Directive 2002/96/EC (known as WEEE) on electrical and electronic equipment waste and must be
disposed of properly. For disposal, contact your distributor or the manufacturer directly.

6.6 Refilling cooling liquid

If you note a noisy sound of the internal pump or the message „Liquid flow too low“ appears there is
probably not enough cooling liquid in the device. Use the provided refill kit to increase the cooling liq­uid level.

Fill the bottle of the refill kit with cooling liquid. If available, use a mixture of 2 parts distilled water and
one part propylene glycol (1,2-propanediol) in order to ensure frost protection till -10°C during storage
and transport. If temperatures are always above 0°C pure distilled water can be used, too.

Screw the lid on the bottle and connect it to the coupling on the right side of the base unit.

Switch on the device, if you have not done so already. Hold the bottle up above device level. Squeeze
the bottle so that the liquid is flowing into the device. Loosen the pressure afterwards to de-aerate the
device.

Disconnect the hoses as soon as no more liquid is flowing into the device and no more air bubbles
coming up into the refill bottle. The device is now filled-up and ready for use.

!

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 33 of 46

7. Specifications

7.1 Specifications and Certification

Designation

Value

Working beam wavelength

808 nm (LinScan 808) oder 980 nm (LinScan 980)

Aiming beam wavelength

635 nm

Maximum power working beam

300 W

Maximum power aiming beam

<1 mW

Working beam laser class

4

Aiming beam laser class

2

Pulse duration

4 – 100 ms

Nominal ocular hazard distance
(NOHD)

4,36 km

Beam divergence

Fast Axis: <1 mrad
Slow Axis: 0,42 rad

Dimensions

Base unit: 30 cm (W) x 30cm (D) x 25cm (H)
Applicator: 15 cm (L) x 10 cm (W) x 20cm (H)

Weight

Base unit: 15 kg
Applicator: 0.9 kg

Electrical safety class
Class I , Type BF Applied Part

Ambient temperature during use

18 ° C to 30 ° C

Humidity during use

<= 90% noncondensing

Ambient temperature during storage
and transport

-10 ° C to 60 ° C

Humidity during storage and
transport

<= 100%
Cooling

Integrated water cooling

Cooling liquid

 mixture of 2 parts distilled water and one part propyl-

ene glycol (1,2-propanediol) for frost protection down
to -10°C

 Pure distilled water in case of storage and transport

at temperatures above 0°C

Electrical Connection

110V-240V at 50Hz, 110V-220V at 60Hz, max. 1750W

Fuses

3AB (6,3x32mm), 250V, 20A Fast acting

Maximum operating altitude above
sea level

2000m
Allowable air pressure during use

795-1050 hPa

Interfaces

 USB 2.0 connector for USB memory sticks
 Foot switch connector for foot switch Steute MKF 2S-

MED SK12

 Door interlock connector for connector Würth El-

ektronik Art-No. 691 361 300 0xx

The medical device meets the requirements of EU Directive 93/42/EEC and the requirements from the
national laws and mandatory standards derived from this directive.

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 34 of 46

7.2 Device Labeling

Name plate

Laser warning label

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 35 of 46

Labeling Symbols

Description

Symbol

Caution/Warning: See Instructions for Use (User Man-

ual)

Catalog Number

Serial Number

Date of Manufacture

Do Not Discard in Trash

Refer to “Instructions For Use (User Manual)"

Manufacturer Symbol

Type BF Applied Part

Protective earth (ground)

European Conformity

TUV Rheinland logo

Laser aperture label

Ambient temperature during storage and transport: -

10 °C to 60 °C

Ambient temperature during use: 18 ° C to 30 ° C

Humidity during use: <= 90% noncondensing

Humidity during storage and transport: <= 100%

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 36 of 46

Fragile, handle with care

Consult Instructions for Use

Do not stack

Avoid moisture

Made in Germany

7.3 Electromagnetic compatibility (EMC)

The medical device was tested according to EN 60601-1-2 on electromagnetic compatibility. Never­theless, it should be noted that RF communication devices can affect electrical medical devices.
Therefore, the medical device must be installed and operated strictly according to the prescribed envi­ronmental and installation instructions. RF devices must be operated at a safe distance, which de­pends on the frequency and the power of the RF device.

In addition, the following precautions should be observed:

Caution!

Hazard: The EMC tests were performed with the device and the

cables and connectors specified by the manufacturer and included
in the delivery of your device. Using other cables or connectors
can negatively affect the EMC of the device. When using such ca­bles or connectors other devices placed in the surrounding could
be disturbed or the other devices could disturb the medical device.

Action: Only use the original cable and / or connectors supplied
by the manufacturer.

Caution!

Hazard: When testing the device for compliance with EN 60601-1-

2 standardized measuring distances are used. These distances
may be greater than the distances to nearby electrical devices that
occur when devices are placed directly next to, above or below the
medical device. With a too tight set-up it cannot be excluded that
the electrical devices interfere with each other and thus a proper
functioning with respect to the intended use is no longer guaran­teed. This does not apply to equipment that the manufacturer has
specified and tested for such a placement.

Action: Do not place electrical devices in the immediate vicinity of
the medical device, except for accessories that were released for
this purpose by the manufacturer.

!

!

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 37 of 46

The medical device may only be used in an electromagnetic environment specified below. The cus­tomer or user of the medical device must verify that the device is used only under these conditions.

Test

Test Level
and Conform­ity

Electromagnetic environment

Irradiated / forwarded emis­sions CISPR 11

Group 1

This medical device uses RF energy only for its
internal operation. That is why it has very low RF
emissions that cause no interference in the vicini­ty of any electronic device.

Irradiated / forwarded emis­sions CISPR 11

Class B

Harmonics
IEC / EN 61000-3-2

Class A

The medical device is suitable for use in all envi­ronments, including domestic use and direct con­nection to household electricity.

Voltage fluctuations / flicker
IEC / EN 61000-3-3

Complies

Electrostatic discharge
(ESD)
IEC / EN 61000-4-2

+ / - 6 kV with
contact
+ / - 8kV in the air

The floors shall be wood, concrete or ceramic. If
the floor is covered with synthetic material, the
relative humidity must be larger than 30%.

Fast transient / burst IEC /
EN
61000-4-4

+ / - 2kV supply
(mains), + / - 1 kV
power supply in­put and output
lines

The power supply must be the one common for a
commercial or clinical setting.

Surge IEC / EN 61000-4-5

+ / - 1kV fed
push-pull, + / ­2kV power supply
common mode

Voltage drops, short inter­ruptions and voltage varia­tions IEC / EN 61000-4-11

5% UT for 0.5 cy­cles
40% UT for 5 cy­cles
70% UT for 25
cycles
<5% UT for 5 sec

The power supply must be the one common for a
commercial or clinical setting. If the user requires
that the medical device works continuously even
in case of interruptions of the supply voltage, it is
recommended to use it with an uninterruptible
power supply.

Magnetic field
IEC / EN 61000-4-8

3 A / m

The magnetic field should be the one common
for a commercial or hospital environment.

Conducted Immunity IEC /
EN 61000-4-6

3Vrms 150kHz to
80MHz

Recommended safety distance: 1.2 * sqrt (P)

Radiated immunity IEC / EN
61000-4-3

3 V / m 80MHz to
1GHz

Recommended safety distance:

1.2 * sqrt (P) below 800 MHz

2.3 * sqrt (P) above 800 MHz

7.4 System and Error Messages

No.

Message

Cause

User Action

101

Trace Server not ready

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

102

Workflow Server not ready

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

103

IO Device not ready

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

104

Service.xml backup/restore
failed

File cannot be loaded

Switch off and on de­vice again. If error per­sists contact service.

105

IODeviceConfig.xml back-

File cannot be loaded

Switch off and on de-

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 38 of 46

No.

Message

Cause

User Action

up/restore failed

vice again. If error per­sists contact service.

201

guarding timeout occurred

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

202

Workflow not ready, please
wait...

Software component needs
more time for starting

No user action required

203

Workflow configuration not
found

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

204

Wrong PIN input. Please try
again!

User has entered wrong PIN

Enter correct PIN. If
you don’t know the cor­rect PIN contact ser­vice

205

Missing data from IO device

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

206

Missing general configuration
file

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

207

General configuration data in­complete (see trace log)

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

208

Missing UI configuration file

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

209

UI configuration data incomplete
(see trace log)

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

210

Missing service configuration file

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

211

Service configuration data in­complete (see trace log)

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

212

Applicator limits data incomplete

Software component miss­ing or defective

Switch off and on de­vice again. If error per­sists contact service.

213

Software update failed

Software update could not
be completed, e.g. because
USB stick has been re­moved

Switch off and on de­vice again. Restart up­date. If error message
occurs use another
USB stick and retry.

214

Software update complete.
Please remove your USB stick
and reboot

Software update has been
completed.

Remove USB stick and
restart device.

215

Saving the operation time failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

216

Starting the operation timer
failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

217

Setting the system time failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

218

Saving the error log to USB stick
failed

USB stick not connected or
damaged

Reconnect USB stick
and wait 30 seconds.

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 39 of 46

No.

Message

Cause

User Action

Then try saving again.
If error persists use
another USB stick.

219

Save errorlog complete

Error log has been saved to
folder GME on USB stick

You may remove the
USB stick now.

220

Creating the directory GME on
the USB stick failed

USB stick not connected or
damaged

Reconnect USB stick
and wait 30 seconds.
Then try saving again.
If error persists use
another USB stick.

221

Saving the settings failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

222

Setting the new PIN failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

223

Saving the production data
failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

224

Service reset failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

225

Saving speaker volume failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

226

Setting speaker volume failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

227

Please fill in all fields

Input data is missing.

Please enter data.

228

Saving timeformat failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

229

Setting timeformat failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

230

Parametertable attribute check
failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

231

Rowidentifier calculation failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

232

Saving switch selection failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

233

Device has to be serviced
(days). Please call service

The admissible service in­terval is exceeded

Please contact GME or
your local distributor
and arrange service
appointment

234

Device has to be serviced
(emission time). Please call ser­vice

The admissible service in­terval is exceeded

Please contact GME or
your local distributor
and arrange service
appointment

249

2. power has to be larger than the

1. power!

Hardware or software compo­nent defective

Switch off and on device
again. If error persists
contact service.

250

The configured power is not in the
working range of the laser!

Hardware or software compo­nent defective

Switch off and on device
again. If error persists
contact service.

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 40 of 46

No.

Message

Cause

User Action

251

2. puls duration has to be lower
than the 1. puls duration!

Hardware or software compo­nent defective

Switch off and on device
again. If error persists
contact service.

252

Decryption of the PIN failed!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

253

Encryption of the PIN failed!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

254

The design configuration is in­complete!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

255

Failed to load design!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

256

Factory default failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

301

guarding timeout occurred

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

302

file open failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

303

Save the language failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

304

Read the language error file
failed

File is missing or corrupted.

Switch off and on de­vice again. If error per­sists contact service.

305

Reset of the pulse counter
failed!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

306

Set of the pulse counter failed!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

401

guarding timeout occurred

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

402

COM-port error

Defective hardware compo­nent

Switch off and on de­vice again. If error per­sists contact service.

403

COM-Port property error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

404

Rx-thread error

No answer from software
component received

Switch off and on de­vice again. If error per­sists contact service.

405

read port error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

406

write port error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

407

protocol timeout occurred

Software component not an­swering

Switch off and on de­vice again. If error per-

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 41 of 46

No.

Message

Cause

User Action

sists contact service.

408

checksum error

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

409

applicator communication error

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

410

no applicator connected

Software component not an­swering

Switch off and on de­vice again. If error per­sists contact service.

411

unknown response message

Wrong message from soft­ware components

Switch off and on de­vice again. If error per­sists contact service.

412

applicator detects a checksum
error

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

413

applicator detects a message
format error

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

414

applicator receives unknown id

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

415

applicator receives no scan pat­tern

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

416

applicator detects scan pattern
error

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

417

scanner data error

Scanner detects wrong/
missing data

Switch off and on de­vice again. If error per­sists contact service

418

applicator detects an CRC- error

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

419

scanner 1 detects an flash CRC
error

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

420

scanner 2 detects an flash CRC
error

Software component defec­tive

Switch off and on de­vice again. If error per­sists contact service.

421

Scanner 1: reference scan failed

Scanner is not operating
properly

Switch off and on de­vice again. If error per­sists contact service.

422

Scanner 2: reference scan failed

Scanner is not operating
properly

Switch off and on de­vice again. If error per­sists contact service.

423

Applicator data error occurred

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

424

Save scanner data failed

Message not transmitted
correctly

Switch off and on de­vice again. If error per­sists contact service

425

No scanner connected

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

430

RF-Generator error occurred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 42 of 46

No.

Message

Cause

User Action

431

RF-Generator standby error oc­curred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

432

RF-Generator laser on error oc­curred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

433

Door interlock open. Please
close door or door interlock con­tact!

Door interlock contact is
open

Close door or connect
both contacts of the
door interlock connect­or.

434

Applicator temperature error oc­curred

Temperature in applicator is
too high or too low

Please wait till temper­ature reaches allowed
range.

435

Foot switch active error oc­curred. Please release foot
switch!

Foot switch has been
pressed for a very long time

Release foot switch or
check if anything
blocks the foot switch.

436

Laser current high error oc­curred. Please restart treatment!

A too high current to the
light source was measured

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

437

Laser current low error occurred.
Please restart treatment!

A too low current to the light
source was measured

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

438

Laser pulse long error occurred.
Please restart treatment!

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

439

Calibration failed! Start calibra­tion again

Hardware or software com­ponent defective

Only for service

440

Illegal scanner position

Scanner damaged or
blocked

Switch off and on de­vice again. If error per­sists contact service.

441

Foot switch is pressed. Please
release foot switch!"

Foot switch has already
been pressed before laser
was put in ready mode.

Release foot switch or
check if anything
blocks the foot switch.

442

Power calibration failed

Hardware or software com­ponent defective

Only for service

443

Scanner move fine error oc­curred

Hardware or software com­ponent defective

Only for service

444

Get scanner position failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

445

Save of the power calibration
failed

Hardware or software com­ponent defective

Only for service

446

Base unit cold side too cold!
Please wait while warming up...

Temperature of the cold side
of the built-in Peltier cooler
is too low.

Please wait till temper­ature reaches allowed
range. Minimal warm­up time is achieved if
device is kept running.

447

Base unit cold side too warm!
Please wait and do not switch
off device!

Temperature of the cold side
of the built-in Peltier cooler
is too high.

Please wait till temper­ature reaches allowed
range. Minimal cooling
time is achieved if de­vice is kept running.

448

Base unit hot side too warm!
Please wait while cooling

Temperature of the hot side
of the built-in Peltier cooler

Please wait till temper­ature reaches allowed

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 43 of 46

No.

Message

Cause

User Action

down...

is too high.

range. Minimal cooling
time is achieved if de­vice is kept running.

449

Applicator is cooling to config­ured skin temperature. Please
wait..

Skin cooling temperature is
too high.

Please wait till temper­ature reaches allowed
range.

450

Hand switch active error oc­curred. Please release hand
switch!

Hand switch has already
been pressed before laser
was put in ready mode.

Release hand switch or
check if anything
blocks the hand switch.

451

Liquid flowrate low. Please refill
cooling liquid or straighten ca­ble!

Not enough cooling liquid is
pumped through the device.
Two causes are possible:

- There is not enough
cooling liquid in the
device

- The applicator cable
is squeezed or
twisted

Fill up cooling liquid.
Check if cable to appli­cator is bent heavily or
twisted. Straighten ca­ble!
Restart device. If error
persists call service.

460

Creation of IO_READ_THREAD
failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

461

Creation of
IO_EMISSION_THREAD failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

462

Applicator error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

463

bootloader in error state

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

464

erase flash failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

465

firmware upload failed

Hardware or software com­ponent defective

Only for service

466

firmware crc error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

467

start application failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

468

File not found

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

469

Queue overflow

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

470

general purpose input/output er­ror

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

471

Unallowed temperature differ­ence at applicator

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

472

Thermoelement Base Unit:
Open circuit

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

473

Thermoelement Base Unit:
Short circuit

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per-

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 44 of 46

No.

Message

Cause

User Action

sists contact service.

474

IODevice configuration not
found

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

475

IODevice configuration data in­complete

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

476

Saving the settings failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

477

Open the registry failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

478

Read computer name from the
registry failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

479

Write computer name into the
registry failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

480

Initialize the WiFi module failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

481

Syntax failure in the applicator
response.

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

482

Laser diode voltage error

Hardware component defec­tive

Please contact service.

483

Laser diode current offset too
low.

Hardware component defec­tive

Please contact service.

484

Laser diode current offset too
high

Hardware component defec­tive

Please contact service.

501

Scanner ignored SSCAN Signal

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

502

Scanner X-Axis Drive Timeout
occurred. Please restart treat­ment!

Hardware or software com­ponent defective

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

503

Scanner Y-Axis Drive Timeout
occurred. Please restart treat­ment!

Hardware or software com­ponent defective

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

504

Scanner Error occurred prior
Laser emission

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

505

Scanner Error occurred while
Laser emission

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

506

Timeout occurred while Laser
emission

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

507

Scanner detects Scanpattern
CRC error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

508

Laser Emission could not be

Hardware or software com-

Switch off and on de-

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 45 of 46

No.

Message

Cause

User Action

started

ponent defective

vice again. If error per­sists contact service.

509

Error while transmitting Scanpat­tern to Scanner

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

510

Scanner ignored SetStandby
command

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

511

Timeout while transmitting
Scanpattern to Scanner

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

512

Scanner X-Axis Safety Error oc­curred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

513

Scanner Y-Axis Safety Error oc­curred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

514

Applicator received no Scandata

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

515

Scanner SSCAN Error occurred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

516

Unknown Calibration received
by Applicator

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

517

Applicator warmup error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

518

Wrong Calibration received by
Applicator

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

519

Wrong warmup position re­ceived by Scanner

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

520

Scanner synchronization failed

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

521

Scanner moves too slow. Please
restart treatment!

Hardware or software com­ponent defective

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

522

Scanner moves too fast. Please
restart treatment!

Hardware or software com­ponent defective

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

523

Handswitch Error occurred

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

524

Thermoelement Sensor 1: Open
Circuit

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

525

Thermoelement Sensor 1: Short
Circuit

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

526

Thermoelement Sensor 2: Open

Hardware or software com-

Switch off and on de-

7. Specifications

GME LinScan Revision 14, dated 2016-06-08 Page 46 of 46

No.

Message

Cause

User Action

Circuit

ponent defective

vice again. If error per­sists contact service.

527

Thermoelement Sensor 2: Short
Circuit

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

528

Laser pulse short error occurred.
Please restart treatment!

Hardware or software com­ponent defective

If error only occurs
once then continue
working. If error occurs
frequently contact ser­vice.

534

Synchronization timeout error oc­curred

Hardware or software compo­nent defective

Switch off and on device
again. If error persists
contact service.

598

Applicator System Tick Error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

599

Applicator detects an Program
CRC error

Hardware or software com­ponent defective

Switch off and on de­vice again. If error per­sists contact service.

7.5 Accessories

The following accessories/ detachable parts are intended to be used with the medical product:

 Foot switch (Item-No. GME1020.2201)
 Protective goggles (Item-No. GME1042.2100)
 Applicator holder (Item-No. GME1040.2102)
 Small spot adapter (Item-No. GME1040.4000)
 Cover Door Interlock (Item-No. GME1020.0124)
 Power cable (Item-No. GME1040.2200)
 Transport box LinScan (Item-No. GME1040.3000)
 Refill kit (Item-No. GME1040.2002)