Operator Manual – ADVATx

Ver. Description Auth Eff. date Appro CQ

ved
A01 Document initiated. TRL - - -
A02 Update to 6.4 – cleaning instructions distance JE 26-08-2012 - -
piece
A03 Updated info added JE 29-08-2012 - -
A04 Update content including warning symbols, TRL 06-10-2012 - -
photos, screen dumps, etc.
A05 Document structure changed. Significant text TRL 06-10-2012 - -
and photos added.
A06 Chapter 5 and 6 shifted around (compared to TRL 19-09-2012 - -
revision A05). Cleaning section moved to
chapter 8.
A07 Error / warning screen dumps added + general TRL 26-09-2012 - -
review. 7.2 Service is incorporated in section
8.5 also named Service. Terminology section
moved from chapter 6 to chapter 4.
A08 Layman review and screen updates based on TRL 11-10-2012 PEN -
doctor review. Intended Use updated with
section about population.
A09 Document page header removed. File name KVS 06-02-2013 PEN 190
and revision printed in section 1. Introduction
only.
“Document not in revision control” text in page
footer removed.
Specs. Table updated.
Section on EMC and RF (IEC 60601-1-2 3ed,
5.2.1.1 a & b) added.
Section on Applied Parts added (sentence TRL
about type B and BF removed in section 6.2).
A list of cables and accessories added – other
cables might have negative impact on EMC
performance (IEC 60601-1-2 3ed, 5.2.2.1 a &
b).
Specification of ”ME Equipment not specified
for use in shielded location” (IEC 60601-1-2
3ed, 5.2.2.2) added.
In section 8.4 specifications are added. Version
added on front page. Section 6.2.2 added - all
part of Nemko’s review. Various clarification,
spelling and grammar (TRL).
A10 Scanner nozzle changed from type B to BF KVS 08-02-2013 PEN 191
Type B label removed
Type BF information on both applicators added
in section 6.2.2
Doublets of “System too hot” errors removed
from error code table. Laser warning &
explanatory label updated.
A11 10.2: “800VA” changed to “900VA”. 2.3: TRL 05-03-2013 PEN 245
comment on skin type V added. Label list in
section 3.2 adjusted according to
001.TRL1224B.A06.REQ.Requirements_labels_l
aser.
CE mark 0459 added in “1. Introduction” and
“Type B” removed.
10.4: table added. 10.5: “cleaning between
patients” added. 6.2: laser beam illustrations
added. 3.1: warnings added. NOHD added to
spec’s.

OPERATOR MANUAL PAGE 1

Operator Manual – ADVATx

Ver. Description Auth Eff. date Appro CQ

ved
A12 Laser aperture label updated KVS 15/03/2013 PEN 258
Explanatory label updated
Beam divergence, NOHD and MPE added in
section 10.3
Refence to 001.MTH1310A.A01.OPS added
A13 Section 3.3. extended with 60825 requirements TRL 22/3 2013 PEN 263
related to eyewear.
Section 10.2 updated with operating specs.
A14 Version now stated on front page. Wording TRL 13/9-2013 PEN 343
improved. Logo: Advalight replaced by ADVATx.
Resp. person added. Specs updated.
A15 Professional spelling & grammar proofreading. TRL 18-10-2013 PEN -
A16 Warning box added in section 2.3. 1319nm TRL 11-02-2014 PEN 421
eyewear added in chapter 8. OD + new stock
number added in section 3.3. Updated example
of error code (sec 7.2). Spelling & grammar.
New MMI screen dumps, photos and adjusted
labels. Sleep mode section added. Based on
TRL1423A “venous lake” and “red hypertrophic
scars” are added to the list of indications in
Intended Use.
A17 Photos updated. DoC added as appendix. Sec TRL 30-08-2014 PEN 495
6.2.1. reworded. 10.2: start-up time removed.
Sleep mode added to “error messages”.
Wording improved. Positioning removed from
label table, touch screen removed from
terminology table, company names removed
from eyewear section. Chapter 8 & 9 merged.
EP (ER) wording made identical to FR. Cleaning
moved to chapter 4. CEO made responsible for
the manual.
A18 Calibration statement added in 9.5. Updated TRL 01OCT 2015 560
DoC.(#560). Photos in 4.0 merged to one. 3.2: 565
labels updated according to ECR 565. Typo in 695
2.2 Intended Use corrected. (#695). 6.4.3: 733
repetition mode added. 6.2.2: polyurethane
replaced by ABS. Operating humidity to be
80%, not 90% as storage/shipping. Distance
pieces added in 8.2.
A19 Room temp box added in section 5.1 /TRL PEN 19APR PEN 785
Sec 9.2 Voltage range adjusted to 120-240V 2017
Sec. 3.2 & 9.4 Label updated after UDI 909
°C  °F calculation error in sect. 9.4 corrected
Sec. 8.2 Safety eyewear #1046 replaced by
#761
Sec. 8.2 Goggles description updated 1014
Sec. 3.2 Explanatory label updated 997
Sec 3.4 Treatment type added
Hand piece removed - All pictures updated
Sec 5.4 voltage range updated
A20 Sec 2.2 Cosmetic removed PEN 27JUN2017 PEN 884
Sec 6.4.4 updated with ref #884 1045
Warnings updated ref to risk analysis
A21 The entire manual has had a major overhaul KVS 20NOV2017 PRL 1042
ensuring a match with SW rev. 31 (ECR1042).
A lot of irrelevant chit-chat and small-talk has
been removed. Accuracy in descriptions has

OPERATOR MANUAL PAGE 2

 Operator Manual – ADVATx

Ver. Description Auth Eff. date Appro CQ

ved
been reviewed and tightened up. Sections have
been moved and doubled information and
descriptions have been removed.
• GUI screen dumps updated
• DoC updated
• EMC references updated to EN 60601-1-
2:2015
• Bottom air inlet filter replacement added
A22 • Company address changed KVS 12JUN2018 MTH 1264
• Type plate updated
• Packaging label updated
• Scanner ID label added
• DoC updated
A23 • Texts and graphics updated to match GUI KVS 27SEP2018 ADE 1255
V11 updates; Case 481, 483
• Repetition mode changes described; Case
470
• Sec. 8.2 Error messages updated
• Sec. 3.2 Table leading text changed
• Transport box photo updated
• DoC updated
A24 • Distance piece with sapphire tip #1663 KVS 27MAR2019 ADE 1504
added including coupling gel classification
• Mains power cord UK #1540 added
• Mains power cord India #1670 added
• Mains power cords description clarified
• Packaging label spelling error updated

Responsibilities

The <CEO> is responsible for the content of the ADVATx Operator Manual:

File name: 001.TRL1232A.A24.MAN.ADVATx Operator Manual.docx

OPERATOR MANUAL PAGE 3

OPERATOR MANUAL

MAR 2019
Revision A24, US

OPERATOR MANUAL PAGE 1

1. Introduction .......................................................................... 6

2. Caution .................................................................................. 7

2.1. Restrictions on use of Class IV laser equipment .................... 7

2.2. Intended Use ......................................................................... 8

2.3. General................................................................................ 10

3. Installation & User Obligations ........................................... 11

3.1. Safety Warnings .................................................................. 11

3.2. Labels and Symbols ............................................................. 12

3.3. Safety and Eyewear ............................................................. 14

3.4. Terminology used................................................................ 16

4. Description of the ADVATx .................................................. 18

4.1. Scanner ............................................................................... 18

4.1.1. Optical output aperture ................................................ 20
4.1.2. Trigger switch ............................................................... 20
4.1.3. Distance piece ............................................................... 22

4.2. Moving the ADVATx ............................................................ 24

4.3. Drawer ................................................................................ 24

5. Cleaning............................................................................... 26

5.1. Scanner ............................................................................... 26

5.1.1. Distance piece ............................................................... 26
5.1.2. Scanner output aperture ............................................... 26

OPERATOR MANUAL PAGE 2

5.2. Cabinet ................................................................................ 26

5.3. Eyewear............................................................................... 27

6. Installation .......................................................................... 27

6.1. Scanner ............................................................................... 28

6.1.1. Connecting the scanner ................................................ 28
6.1.2. Disconnecting the scanner ............................................ 30

6.2. Foot pedal ........................................................................... 32

6.2.1. Foot pedal dummy plug ................................................ 32
6.2.2. Foot pedal (optional) .................................................... 33

6.3. External interlock ................................................................ 34

6.4. Safety key ............................................................................ 35

6.5. Mains power connection..................................................... 36

6.6. Emergency Stop button ....................................................... 37

6.7. Environment........................................................................ 38

7. Operating the ADVATx ........................................................ 39

7.1. Getting ready ...................................................................... 39

7.2. Operating the ADVATx ........................................................ 40

7.3. Graphical user interface buttons and/or indicators ............ 40

7.4. Principle of operating the ADVATx ...................................... 41

7.5. Preset protocols .................................................................. 46

7.6. STANDBY/READY mode....................................................... 47

OPERATOR MANUAL PAGE 3

7.7. Automatic revert to STANDBY............................................. 49

7.8. Adjusting fluence ................................................................ 49

7.9. Scanner pattern options...................................................... 50

7.9.1. Square .......................................................................... 50
7.9.2. Line ............................................................................... 52
7.9.3. Circle ............................................................................. 53

7.10. Repetition mode .............................................................. 54

7.11. Adjusted settings example............................................... 55

7.12. Sleep mode ...................................................................... 56

7.13. ADVANCED operating mode ............................................ 57

7.14. Turn the ADVATx OFF ...................................................... 57

8. Equipment modifications and Error Codes .......................... 58

8.1. Equipment modifications .................................................... 58

8.2. State information and Error codes ...................................... 58

8.2.1. ERROR - System too hot ................................................ 59
8.2.2. ERROR - System too cold ............................................... 59

9. Applied parts & accessories ................................................ 60

10. Technical Specifications ...................................................... 62

10.1. Output power .................................................................. 62

10.2. Fluence ............................................................................ 62

10.3. Biological evaluations ...................................................... 62

OPERATOR MANUAL PAGE 4

10.4. Specifications ................................................................... 62

10.5. Storing and transportation .............................................. 64

10.6. Service ............................................................................. 66

10.6.1. Air inlet filter replacement ........................................ 66

10.7. Disposal ........................................................................... 69

10.8. Warranty Terms and Conditions ...................................... 69

10.9. Guidance and manufacturer’s declaration – EMC topics . 70

11. APPENDIX A – Declaration of Conformity ........................... 73

OPERATOR MANUAL PAGE 5

1. Introduction
Congratulations on the purchase of the ADVATx. Rigorous quality control
and testing at the manufacturing plant ensures the highest level of quality
and reliability. This product is the result of groundbreaking developments
within solid-state laser technology and is patented globally.

The ADVATx incorporates several fail-safe systems and conforms to

international standards for medical electrical equipment, IEC 60601-1:2006,
IEC 60601-2-22:2013 and IEC 60825-1:2007 and is CE marked according to
Medical Device Directive 93/42 EEC. CE mark is CE0459.

The ADVATx is a Class 1 medical electrical equipment with BF Applied Parts.

A scanner is connected to the ADVATx for expanded treatment modalities.

The ADVATx is not sensitive to the use of radiofrequency communication

equipment such as mobile phones.

Advalight is ISO 13485 certified and is the manufacturer of the ADVATx.

Advalight ApS
Industriparken 22A
2750 Ballerup
DENMARK
CVR no. (VAT no.): 29 93 52 70
www.advalight.com

OPERATOR MANUAL PAGE 6

2. Caution
ADVATx is a Class IV laser, which emits potentially harmful visible and
invisible laser radiation.

1. Avoid exposure to direct and scattered radiation.

2. Patients and operators of the ADVATx must wear the appropriate

safety eyewear.
3. Read the Operator Manual carefully before installation and use.

4. The product must be configured and operated in accordance with

the operator’s manual. Operation may only be carried out by
operators that have received the proper training on the product
(or similar) and the operator must be cleared by the local
authorities for the particular treatment that he/she is to carry out.
5. The ADVATx may only be serviced and repaired by authorized
service personnel.

When the product is not in use, it must be stored in a safe place, and
inaccessible to unauthorized personnel.

IMPORTANT!
Warnings and important information are emphasized by being written
in a text box.

2.1. Restrictions on use of Class IV laser equipment

The ADVATx is intended solely for use by clinicians trained in the use of
medical lasers. All safety precautions for Class IV laser equipment must be
followed.

The clinicians are responsible for evaluating each patient’s suitability for the
suggested treatment and are furthermore responsible for informing the
patient of any potential side effects and risks associated with the actual
treatment as well as pre-and post-treatment and care.

All operation of the ADVATx is based upon the operator’s knowhow and
experience. The operator is responsible for correct diagnosis and treatment.

OPERATOR MANUAL PAGE 7

2.2. Intended Use
The ADVATx is specially developed for dermatological treatments i.e. skin
disorders e.g. in the face, on the legs or hands, but potentially everywhere
on the body.

The intended use of the ADVATx is “Medical treatment of vascular and

pigment related skin disorders, including skin rejuvenation and benign
cutaneous lesions, using laser light.”

The expected clinical end-point is a visual improvement and not a total

clearance e.g. a bleaching of a port wine stain, reduction of inflammatory
acne, reduced and less visual rosacea, etc. This is standard end-point in the
aesthetic and medical laser industry, and patients are informed that several
treatments are often required to obtain the “best possible” clinical
outcome.

The ADVATx, operating at 589 nm, is indicated dermatologic treatment of

benign cutaneous vascular lesions including but not limited to:

- Telangiectasias
- Spider veins, both facial and leg

- Port wine stains

- Rosacea
- Melasma

- Hemangiomas
- Hyper pigmentation
- Venous Lakes
- Red or hypertrophic scars

- Skin rejuvenation

The ADVATx, operating at 1319 nm is indicated for:

- Skin rejuvenation
- Reduction of acne scars
- Reduction in the appearance of pores
- Treatment of mild and moderate inflammatory acne vulgaris

OPERATOR MANUAL PAGE 8

OPERATOR MANUAL PAGE 9
2.3. General
The Operator Manual is designed to provide the operator with the
information and expertise needed to operate the ADVATx in a safe manner.
The manual is subject to change without prior notice.
Normal use is defined as dermatological treatments at clinics or hospitals
performed by an educated clinician i.e. personnel with a medical degree
applying to the specific local regulatory and safety requirements.
The intended patient population for the ADVATx is people with Fitzpatrick
skin type I to IV. The laser light may be applied to unbroken/uninjured skin
all over the body, however, do not use ADVATx on eyelids or the genitalia as
this might potentially be dangerous for the patient. Also, do not treat
arterial malformations with laser or similar equipment as these are located
in depth of the skin. A normal treatment setting is defined as a
standing/sitting clinician, or operator, treating a lying/sitting patient both
wearing the required safety eyewear (nobody else is present in the room).
A more detailed explanation of the clinical aspects can be found in the
“Clinical Manual – ADVATx”.

WARNING!
Do not use ADVATx on eyelids or genitalia as this might be potentially
dangerous for the patient.
Never treat arterial malformations with laser or similar equipment.

OPERATOR MANUAL PAGE 10

3. Installation & User Obligations
The ADVATx has been designed and tested for safety for both the user and
patient. It is ultimately the operator’s responsibility to introduce safe
operation and practices that ensures the safety of personnel and patients.

3.1. Safety Warnings

WARNING!
Electrical Safety: The product must be correctly connected to a
hospital or clinic earth grounded wall socket.
Optical Safety: Avoid exposure to laser radiation by wearing
appropriate protective eyewear whenever the
ADVATx is active.
Fire and explosion: The risk of fire and/or explosion exists when a
laser is used in the presence of flammable
materials, solutions, gasses, or in an oxygen-
enriched environment. This includes normal use
e.g. in the presence of cleaning solvents used for
disinfection or endogenous gases. Disinfecting
solvents must be allowed time to evaporate before
the laser is used.
Tissue particles: Laser fume and/or plume may contain viable tissue
particulates.

OPERATOR MANUAL PAGE 11

3.2. Labels and Symbols
The following labels identify the ADVATx.
Label Symbol Reference
Advalight Product name
logo EN 60601-1 3rd
7.2.4

Type plate Manufacturer

data, Serial
Number, WEEE
disposal, weight,
CE0459 mark, type
Body Floating
(scanner),
production date,
UDI data etc.
Scanner ID

Scanner EN 60601-1 3rd

serial 7.2.4
number

OPERATOR MANUAL PAGE 12

The following symbols highlight a possible safety risk when operating the
ADVATx.
Label Symbol Reference
Emergency 60601-2-22 no.
laser stop 101

Optical 60601-2-22 no.

fiber 116

Laser EN 60825-1:2008
Warning section 5.1

Explanatory EN 60825-1:2008
label section 5.1
CFR 1040.10
21 CFR 1040.10 &
1040.11
Remote EN 60601-2-22
interlock

Mains inlet Advalight label

Laser EN 60825-1 4.7.4

Aperture

OPERATOR MANUAL PAGE 13

3.3. Safety and Eyewear
All personnel and patients in the treatment room must wear protective
eyewear as well as protection against scattered radiation of 589 nm and
1319 nm as light might be reflected.
Injury to the eyes and/or the epidermis can result from either direct or
scattered laser radiation. In addition, the ADVATx can cause severe burns
when light is emitted directly on the skin.

When operating the ADVATx, the wavelength is shown on the buttons in

the Menu screen and in the INFO box in the Settings screen. This can and
must be observed prior to choosing/pressing READY and activating the
ADVATx. Make sure that operator eyewear matches the wavelength, and
that the patient’s eyes are protected as well.

The chosen wavelength is 589 nm

IMPORTANT!
589 nm is visible light in the yellow spectrum whereas 1319 nm is
invisible to the human eye. In doubt, check the Settings screen and
make sure the ADVATx is not active

Protective eyewear is designed to protect against accidental exposure to

laser radiation, not deliberate direct exposure.
The eyewear should be checked periodically for signs of wear or damage
and be examined for suitability on each occasion prior to use (eyewear
protection must match the wavelength of the laser beam).

OPERATOR MANUAL PAGE 14

The eyewear worn by the operator must allow visible light transmission and
the ability to see warning lights and indicators through the filters. Patient
eyewear should be laser-blocking eyewear.
Eyewear appropriate for the ADVATx operator can be ordered from the
ADVATx distributor.

WARNING!
All personnel and patients present in the
operation room must wear appropriate
protective eyewear when ADVATx is
activated.
The protective eyewear must protect
against the wavelengths 589 nm (OD5)
and 1319 nm (OD7) and be of a quality
corresponding to IEC 60825, ANSI Z136.1
and EN 207.
The wavelength in use is shown in the
INFO box in the Settings screen and on
the buttons in the Menu screen.

OPERATOR MANUAL PAGE 15

3.4. Terminology used
Term Meaning

Applicator The piece of equipment the operator holds in his/her

hand while performing a treatment.
The ADVATx comes with a scanner.

Operator The person responsible for operating the ADVATx i.e.

switching the ADVATx ON, choosing the treatment
setting, treating patients as well as taking all safety
precautions.

Main menu The system will start in the Main menu when power up.
The main menu is split into Treatment and Advanced. In
Treatment, the operator selects preset indicated
dermatologic treatments and in Advanced treatment all
settings can be selected by the operator.

Fitzpatrick A recognized numerical classification schema for the

scale color of skin (invented by Thomas B. Fitzpatrick, a
Harvard (USA) dermatologist).
Fitzpatrick TB: Soleil et peau. J Med Esthet 1975;2:33034

Fluence The fluence is the energy delivered per area, and the
fluence is measured in J/cm2 (Joules per square
centimeter).

STANDBY The mode where the ADVATx waits for the operator to
mode either press the green READY button, and go into ACTIVE
mode, or for the operator to adjust the settings prior to
doing this.

Scan area The area covered by multiple spots, forming the pattern
chosen by the operator. This only applies to the scanner.

Pulse time The time that each single spot is being exposed to
light/energy when the ADVATx is active.

Repetition Laser spot emissions repeated with a fixed pause

mode between the spots.

Wavelength Different colors of light represent different wavelengths.

E.g. is yellow light around 585 – 595 nm.

OPERATOR MANUAL PAGE 16

OPERATOR MANUAL PAGE 17
4. Description of the ADVATx

Dashboard

Emergency STOP Scanner dock

Push/pull handle Scanner

Safety railing
All directional
wheel

4.1. Scanner
The ADVATx is operated with the attached scanner.

Distance piece
Optical output lock nut
aperture

Handle

Distance piece

Trigger switch Scanner cable

The scanner is designed to be the physicians versatile hand tool used in all
aspects of ADVATx treatments.

The handle is designed to ensure the operator a firm grip on the scanner
ensuring maximum control and maneuverability.

OPERATOR MANUAL PAGE 18

The scanner cable is a reinforced tube protecting the optical and electrical
connection between the ADVATx cabinet and the scanner.

OPERATOR MANUAL PAGE 19

4.1.1. Optical output aperture
The scanners optical output aperture is the ADVATx systems laser output
port. The output port delivers laser light to the target. A green guide laser
light pointing out the target is emitted when the ADVATx system is in READY
mode.

Distance piece
Optical output lock nut
aperture

Target plane

When placing the distance piece gently onto the target surface it is ensured,
that the treatment spot diameter of 1 mm is maintained. Hereby the
delivered fluence corresponds to the fluence set on the ADVATx.

4.1.2. Trigger switch

Pressing the scanners trigger switch firmly activates the ADVATx when set
into READY mode. Hereby treatment laser light is emitted onto the target.

Trigger switch

The scanner delivers treatment laser light to all spots defined in the
selected scan pattern. Refer to section 7.9 for scan pattern details.

OPERATOR MANUAL PAGE 20

OPERATOR MANUAL PAGE 21
4.1.3. Distance piece
The mounted distance piece can be rotated 360° by loosening the lock nut.
Loosen the lock nut by rotating it counter clockwise and fasten it again by
rotating it clockwise.

The distance piece is easily replaced by unscrewing the lock nut, swapping
the distance piece and re-mounting the lock nut. This allows the operator to
select the distance piece most suitable for the actual procedure.

The ADVATx scanner is delivered with 3 distance pieces.

Sapphire window distance piece for

passive contact skin cooling.

7/8 circle distance piece

1/8 circle distance piece

1/2 circle distance piece Optional

OPERATOR MANUAL PAGE 22

The sapphire window distance piece allows passive cooling of the area
being treated. Gently apply a coupling gel 1 onto the skin before starting the
procedure and hereafter conduct the treatment with the sapphire window
distance piece.

WARNING!
- Ensure, that the ADVATx is STANDBY mode when adjusting or
replacing the distance piece.
- Care should be taken not to contaminate the scanners optical output
aperture when adjusting or replacing the distance piece.

1
The gel must comply with MDD 93/42/EEC and be recognized as a Medical Product
Class I (Annex VII, rule 1)

OPERATOR MANUAL PAGE 23

4.2. Moving the ADVATx
Moving the ADVATx in the daily setting, from ward to ward in the hospital
or clinic must be done by pulling and pushing via the appropriate handles
and grips. The four all-direction-wheels ensure a very maneuverable and
easy to move the ADVATx.
Prior to moving the ADVATx, ensure that the scanner cable is placed inside
the “safety railing” on the lower front of the ADVATx. Thereby, the
likelihood of the scanner cable being caught and damaged during moving
the ADVATx is minimized.

Wheel lock

The two front all-direction-wheels can be locked, making it difficult to move

the ADVATx. This is advisable during shipping but can be used at any time
by the operator.

4.3. Drawer
For your convenience, the ADVATx includes a large drawer for easy storing
of protective eyewear, Operator Manual, etc.

Drawer

OPERATOR MANUAL PAGE 24

OPERATOR MANUAL PAGE 25
5. Cleaning
The ADVATx scanner is an optical delivery device with an optical lens
aperture intended for use as a non-sterile device.

5.1. Scanner

5.1.1. Distance piece

The distance piece on the scanner should be treated with care and kept
clean, using a soft cloth lightly moistened with a mixture of 70%
demineralized water and 30% alcohol. Cleaning should be done between
patients.
5.1.2. Scanner output aperture
The scanners optical output aperture should be checked frequently. The
optical output may become contaminated during use, from smoke, debris
or dust, which will affect the optical performance.

Optical output aperture

Use a cotton swab or camera lens cleaning tissue lightly moistened with a
high-quality window cleaner for cleaning the optical aperture. A proper
technique is essential to a long life of the optical output lens. Gently swipe
the cotton swab or lens tissue paper across the surface in a single “swipe”
movement, note; use only once. Repeat if required until all visible
contaminants are removed.

5.2. Cabinet
The ADVATx cabinet surface and dashboard can be carefully vacuumed, and
dust can be removed by using a slightly damp piece of cloth. For cleaning
the touchscreen, use slightly damp piece of cloth.

OPERATOR MANUAL PAGE 26

5.3. Eyewear
Protective eyewear is easily rinsed using a mild detergent and tab water.

6. Installation
Before installation of the ADVATx, it is important to ensure that the items
shipped with the system are located and visually checked for any transport
damages.
The ADVATx comes with the following accessories:
- Scanner
- Foot pedal dummy plug
- Foot pedal with wire (optional)
- External interlock plug

- Safety keys
- Power cord with ground connection
- Protective eyewear for 589 nm and 1319 nm

- A pair of patient safety eyewear

- Operator Manual

To get the ADVATx ready for treatments, the operator must ensure, that the
scanner, the foot pedal dummy or the foot pedal dummy plug, the safety
key, the interlock dummy plug and the power cord are installed/connected
correctly. Refer to section 6.1 to 6.5 for details.

OPERATOR MANUAL PAGE 27

6.1. Scanner

Electrical connector

Optical connector

IMPORTANT!
When handling the optical connector plug great care should be taken
not to contaminate the optical openings.
Contaminated optical surfaces may lead to a degradation of the
ADVATx output power or system failure.

6.1.1. Connecting the scanner

The scanner must be connected to the ADVATx on the front of the system.

Remove the transparent protective

cap form the optical connector
socket.

Remove the yellow protective cap

from the optical connector plug.

OPERATOR MANUAL PAGE 28

Align the optical connector plug with
the optical connector socket.
Ensure, that the small pin on the
connector is pointing upwards.

Slide the optical connector plug

gently into the optical connector
socket.
A slot in the optical connector socket
guides the pin when inserted.

Gently push the optical connector

plug into the spring-loaded optical
connector socket until it can’t be
inserted and further.
Rotate the optical connector plug
clockwise until it is blocked and allow
the internal spring-loaded
mechanism to lock the optical
connector plug by slowly loosening
the grip on the connector plug.

The scanners electrical connector is

inserted into the adjacent connector
by aligning the tab on the plug with
the red dot on the socket and
hereafter gently pushing the plug
into the socket.

OPERATOR MANUAL PAGE 29

6.1.2. Disconnecting the scanner
If required, the scanner can be disconnected from the ADVATx when the
system is turned OFF or when it is in STANDBY mode.

The scanners electrical connector is

easily detached from the ADVATx by
holding onto the plugs metal cap and
pulling it gently out of the socket.

Gently push the optical connector

plug into the spring-loaded optical
connector socket until it can’t be
inserted and further.
Rotate the optical connector plug
counter clockwise until it is blocked
and allow the internal spring-loaded
mechanism to push the optical
connector plug outwards.

Slide the optical connector plug

gently out of the optical connector
socket.

Install the yellow protective cap on

the optical connector plug.

OPERATOR MANUAL PAGE 30

 Insert the transparent protective cap
into the optical connector socket.

IMPORTANT!
Do not bend the scanner cable connecting the scanner and the ADVATx
(e.g. do not force it into an unnatural bend) as this might damage the
optical fiber.

OPERATOR MANUAL PAGE 31

6.2. Foot pedal

Foot pedal connector

The ADVATx requires connection of either a foot pedal dummy plug or a

foot pedal.
6.2.1. Foot pedal dummy plug
The foot pedal dummy plug must be connected to the ADVATx on the left-
hand side of the cabinet below the handle bar.
The foot pedal dummy plug is easily detached from the ADVATx by pulling
the plug gently out of the cabinet.
The foot pedal dummy plug is inserted into the socket by aligning the tab on
the plug with the red dot on the socket and hereafter gently pushing the
plug into the socket.

OPERATOR MANUAL PAGE 32

6.2.2. Foot pedal (optional)
The cable from the foot pedal must be connected to the ADVATx via the
foot pedal connector on the left-hand side of the cabinet below the handle
bar.
The foot pedal connector is easily detached from the ADVATx by pulling the
connector gently out of the cabinet.
The foot pedal connector is inserted into the socket by aligning the tab on
the cable connector with the red dot on the socket and hereafter gently
pushing the connector into the socket.

Foot pedal wire hoop

Foot

The foot pedal wire should be put through the foot pedal wire hoop to
minimize the risk of the wire incidentally getting caught by a person or
trapped in the wheel.
Foot pedal wire allows the foot pedal to be positioned approx. 2 meters (6
ft.) from the ADVATx.

IMPORTANT!
The ADVATx can be activated only if the foot pedal or a foot pedal
dummy plug is installed.

OPERATOR MANUAL PAGE 33

6.3. External interlock

External
interlock

The external interlock is located on the left-hand side of the ADVATx just
below the handle bar. National regulatory requirements must be applied
when operating the ADVATx.
The external interlock is easily detached from the ADVATx by pulling the
plug gently out of the cabinet.
The external interlock is inserted into the socket by aligning the tab on the
plug with the red dot on the socket and hereafter gently pushing the plug
into the socket.
An external interlock for door switch operation can be supplied by your
local Advalight distributor.

IMPORTANT!
The ADVATx can be activated only if the external interlock or a wired
door switch plug is installed.

OPERATOR MANUAL PAGE 34

6.4. Safety key

Safety key

The safety key is located on the right-hand side of the ADVATx just below
the handle bar.
The safety key must be in the ON position for the ADVATx to deliver laser
light. Setting the safety key in the OFF position will stop all laser activity.
The safety key can be removed from the ADVATx preventing unpermitted
laser emission.

IMPORTANT!
The ADVATx can be activated only if the safety key is in the ON
position.

OPERATOR MANUAL PAGE 35

6.5. Mains power connection
The mains power inlet is located on the right-hand side of the ADVATx just
below the handle bar.
With the mains power switch in its OFF/“O” position connect the included
mains power cord to the ADVATx power inlet and a correctly grounded
mains power wall socket 120 – 240 VAC.
During transportation or when moving the ADVATx the power cord should
be wrapped around the power cord hook and hoop or removed to avoid
that the cord gets damaged.

Mains switch

Fuse box
Power inlet

Power cord hook

WARNING!
Connecting the ADVATx to a non-grounded mains power wall socket
will void patient and operator safety.

A fuse box containing two fuses is located just above the mains power cord
inlet. Refer to section 10.3 for fuse details.

OPERATOR MANUAL PAGE 36

6.6. Emergency Stop button
The red Emergency STOP button is located on the front of the ADVATx.
Ensure, that the Emergency STOP button is released prior to switching on
mains power.

Emergency STOP

The Emergency STOP button should be used in situations of emergency

where an immediate system stop is wanted. All laser emission is
immediately halted when the Emergency Stop button is pressed.
A firm press on the Emergency Stop button halts all laser emission and
engages a system lock preventing further laser emission. The system lock
must be released to allow further use of the ADVATx.
The system lock is released by the following actions:
1. Rotating the Emergency Stop button counter clockwise until the
spring-loaded button is ejected.
2. Turn the ADVATx OFF by setting the mains power switch in the
“O” position.
3. Turn the ADVATx ON by setting the mains power switch in the “I”
position.

OPERATOR MANUAL PAGE 37

6.7. Environment
Temperature, humidity and positioning requirements

The ADVATx is designed to operate within normal room temperatures,

18 – 27 °C (63 – 81 °F) and humidity below 80%.
Ensure that a minimum distance of 30 cm (1 ft.) from the all sides of the
ADVATx cabinet to walls, furniture and other equipment is maintained.
The unit must be allowed to acclimatize to room temperature before use,
following exposure to extreme temperatures variations e.g. during
transportation. Acclimatization may take a few hours.

IMPORTANT!
- When in use do not place the ADVATx cabinet next to or in front of
other heating sources such as radiators or other heat generating
equipment.
- Keep the room temperature between 18 – 27 °C (63 – 81 °F).
- The ADVATx will not power-up if internal temperatures are below
15 °C (59 °F).

OPERATOR MANUAL PAGE 38

7. Operating the ADVATx

7.1. Getting ready

Install the ADVATx as described in section 6.
Power-up Ensure, that the mains power switch is in the “O” position.

Connect the ADVATx to a grounded wall socket and set the

mains power switch in the “I” position.

When switched on 3 beeps are emitted and the ADVATx

logo displayed. Within one minute the Menu screen is
displayed.

Warm up The ADVATx will warm up and within a few minutes be

ready to operate.

When the Menu screen is shown, the operator can start to choose the
settings for the treatment of the specific patient.

IMPORTANT!
If one or more of the required parts described in section 6 is not
installed a warning message is displayed on the screen.

OPERATOR MANUAL PAGE 39

7.2. Operating the ADVATx
The core of the ADVATx is a laser module that delivers either the
wavelengths 589 nm or 1319 nm, that controlled by software allows the
operator flexibility in setting the optimal treatment parameters.
The graphical user interface is optimized to provide the operator with a
clear overview of the ADVATx system and an intuitive control of its features.

7.3. Graphical user interface buttons and/or indicators

The ADVATx systems graphical user interface operates with buttons and
state indicators.
Buttons are used for user interface navigation and settings adjustment.
Refer to the illustration below.

Disabled button
A disabled button is colored grey and does
not accept user input.
Enabled button
An enabled button is colored blue and
accepts user input.
Selected option button
Option buttons have a green indicator bar
indicating when the option is selected.
Deselected option button
Option buttons have a grey indicator bar
indicating when the option is not selected.

OPERATOR MANUAL PAGE 40

The “Standby” and “Ready” buttons can either be disabled, enabled or act
as indicators. When used as indicators the “button” does not accept user
input.

Disabled “Standby” button

User inputs are not accepted
Enabled “Standby” button
User inputs are accepted
STANDBY mode indicator
The green “Standby” indicator indicates, that
the ADVATx is in STANDBY mode.
Disabled “Ready” button
User inputs are not accepted
Enabled “Ready” button
User inputs are accepted
READY mode indicator
The red “Ready” indicator indicates, that the
ADVATx is in READY mode.

Only the “Standby” and “Ready” buttons can act as indicators as well as
buttons.

7.4. Principle of operating the ADVATx

In short, the operator must go through three steps prior to treating the
patient.

A. Decide on treatment
In the Menu screen, the operator chooses the clinical indication
(skin disorder) to be treated. A press on a Menu screen indication
button brings the operator to the Settings screen.

B. Decide patient’s skin type

On the Settings screen, the operator must decide on and choose
the patients skin type on a Fitzpatrick scale. When the skin type is
chosen, the ADVATx sets a default fluence level for the treatment.

C. Review or adjust settings

OPERATOR MANUAL PAGE 41

 The operator reviews or adjusts the default fluence value, etc.
keeping his/her clinical experience in mind, and sets the ADVATx
into READY mode by pressing the blue “Ready” button.

When the ADVATx is in READY mode a low power green guide laser light
outlines the selected treatment area. The green laser light is emitted from
the scanners optical output “LASER APERTURE”.
The treatment laser light is immediately emitted from the scanners optical
output “LASER APERTURE” when either the scanner trigger switch or the
foot pedal is pressed.

WARNING!
- Laser light is immediately emitted if either the foot pedal of the
trigger switch on the scanner is pressed.

The following is an example following the principle of operation described.

A. Decide treatment

In the Menu screen the operator must decide the

clinical indication to treat by pressing an indication
button.
589 nm - indications are listed in the left side of the
Menu
1319 nm - indications are listed in the right side of
the Menu

OPERATOR MANUAL PAGE 42

OPERATOR MANUAL PAGE 43
B. Decide patient’s skin type

In the Settings screen the operator must decide the

skin type to treat by pressing one of the five enabled
skin type buttons.

C. Approve or adjust settings

The default settings are typical values that might be inappropriate when
treating the specific patient. Hence, the setting must always be reviewed,
adjusted and finally approved by the operator.
Sections 7.8 to 7.10 describes how to adjust treatment parameters.
The blue “Ready” button should be pressed when all settings are reviewed
and acknowledged, and the operator is ready to begin treatment.

OPERATOR MANUAL PAGE 44

 Review/adjust treatment settings and press “Ready”

READY mode
indicator is lit

Settings screen when the blue “Ready” button has

been pressed and the ADVATx set into READY mode.

When the ADVATx is in READY mode a green guide laser light outlines the
selected treatment area. Treatment laser light is emitted immediately from
the scanners optical output “LASER APERTURE” when either the scanner
trigger switch or the foot pedal is pressed.

IMPORTANT!
When the ADVATx is in READY mode the
exclamation sign is displayed next to the red READY
mode indicator.

Laser light is immediately emitted if either the foot

pedal of the trigger switch on the scanner is pressed.

Laser light emission is immediately halted if pressed

trigger mechanism is released.

OPERATOR MANUAL PAGE 45

 Press the foot
pedal or
scanner trigger
switch to
activate the
ADVATx

The ADVATx is ACTIVE emitting laser light.

IMPORTANT!
A laser warning symbol is displayed then the laser is
in ACTIVE mode.

A clear BEEP tone is emitted from the ADVATx when

it is in ACTIVE mode.

IMPORTANT!
- Change mode from READY to STANDBY by pressing the blue
“Standby”.
- The ADVATx is forced into STANDBY mode if the treatment
settings are altered when in READY mode.

7.5. Preset protocols

The ADVATx has a set of preset protocols describing the fluence level and
the scanner pattern suited for the chosen indication and the selected skin
type.
The preset protocols are suggestions to the operator based on expert input
and published literature.
Due to safety, the operator must always ensure that the settings are correct
and that they are chosen for each specific patient.

OPERATOR MANUAL PAGE 46

The ADVATx does not present the option of saving the operator’s own
settings.
A more detailed explanation can be found in the “Clinical Manual –
ADVATx”.

7.6. STANDBY/READY mode

The ADVATx is by default in STANDBY mode and must by the doctor
manually be set into ACTIVE mode to allow laser emission.
STANDBY mode is the fundamental system state when selecting an
indication and adjusting treatment parameters.
The ADVATx “Standby”/”Ready” buttons and status indicators operate
according to the following scheme.

STANDBY

ADVATx not ready to operate. “Ready” button disabled.

STANDBY

ADVATx in STANDBY mode. “Ready” button enabled.

READY

ADVATx in READY mode. “Standby” button enabled.

When pressing the blue “Ready” button the transition from STANDBY into
READY mode does not occur instantaneously. While the transition is in
progress an hour glass is displayed adjacent to the “Ready” button. When
READY mode is entered an exclamation, sign is displayed.

In Preparing the ADVATx for operation.

transition

READY The ADVATx is in READY mode.

Laser light is immediately emitted if
either the foot pedal of the trigger
switch on the scanner is pressed.

OPERATOR MANUAL PAGE 47

OPERATOR MANUAL PAGE 48
7.7. Automatic revert to STANDBY
If the ADVATx is left in READY mode it automatically reverts to STANDBY
mode 5 minutes after the last user interaction with the ADVATx.
This ensures, that the ADVATx is not unintentionally left in a potentially
unsafe state.

7.8. Adjusting fluence

On the Settings screen it is possible to adjust the default set fluence.

Press the “+” button to increase

the fluence value.
Right “+” button: Step size +1
Left “+” button: Step size +10

Press the “-” button to decrease

the fluence value
Right “-” button: Step size -1
Left “-” button: Step size -10

OPERATOR MANUAL PAGE 49

7.9. Scanner pattern options
When using the scanner, the pattern can be changed by pressing the
preferred pattern – choices are square, line or circle.

7.9.1. Square
The first scanner pattern option is “Square”. The scan area can be adjusted
by the operator to 5x5 mm, 7x7 mm or 10x10 mm by pressing the preferred
scan area button. The filling factor is either “Low”, “Medium” or “High”.

The operator has chosen a

10x10 SQUARE pattern with a
medium spot density

Low Low spot density

- Spot diameter 1mm
- 5x5 mm pattern sample
Medium Medium spot density
- Spot diameter 1mm
- 5x5 mm pattern sample
High High spot density
- Spot diameter 1mm
- 5x5 mm pattern sample

OPERATOR MANUAL PAGE 50

OPERATOR MANUAL PAGE 51
7.9.2. Line
The second scanner pattern option is “Line” i.e. the scanner emits light
spots in a horizontal line. When the “Line” option is chosen, the operator
must choose the number of spots in the line to be either 5 spots, 5 spots
separated by a space or 10 spots in a line.

The operator has chosen a 10

spot LINE pattern

5 5 spots on line touch each other

- Spot diameter 1 mm
- Line length 5 mm
5 spaced 5 spots spaced on line
- Spot diameter 1 mm
- Line length 9 mm
10 10 spots on line touch each other
- Spot diameter 1 mm
- Line length 10 mm

OPERATOR MANUAL PAGE 52

7.9.3. Circle
The third scanner pattern option is “Circle” i.e. a circular area will be
covered with spots touching each other. Options are a circular pattern of
effectively 1 mm, 2 mm or 3 mm in diameter.

The operator has chosen a

CIRCLE pattern forming a circle
effectively 3 mm in diameter

1 mm One single spot

- Spot diameter 1mm
2 mm 3 spots forming circle
- Spot diameter 1mm
- Effective spot diameter
2 mm
3 mm 7 spots forming circle
- Spot diameter 1mm
- Effective spot diameter
3 mm

OPERATOR MANUAL PAGE 53

7.10. Repetition mode
Repetition mode is available only when the scanner pattern “Circle” or
“Line” is selected.
The default setting is “off” (no repetition) i.e. the treatment laser light will
be emitted only once when the scanner trigger switch or the foot pedal is
pressed. However, when enabling “repetition mode” emission of the
pattern will be repeated as long as the scanners trigger switch, or the foot
pedal is pressed.
There are two repetition intervals available to the operator. The interval or
pause between repeated laser emissions is selectable between 0.25
seconds or 0.50 seconds.
The repeated laser emission maintained for as long as the scanners trigger
switch, or the foot pedal is pressed.
A maximum of 100 repeated patterns in total can be delivered. The
scanners trigger switch, or the foot pedal must be released and re-activated
to start another repeated scan.

IMPORTANT!
When operating the ADVATx in repetition mode, it is important to
move the scanner in between laser pulses to control the light/energy
exposure of the skin.

OPERATOR MANUAL PAGE 54

7.11. Adjusted settings example
In the example below, the operator has chosen the following:
1. Decided that the patients skin type on the Fitzpatrick scale is type
III
2. Use the default fluence value 10 J/cm2.
3. Chosen a 10x10mm Square scan pattern

4. Chosen filling factor Medium

The operator must review the settings carefully before starting the
treatment!

WARNING!
- Selecting a skin type setting that does not match the skin type of
the patient may harm the patient.
- When not treating, place the scanner in its designated dock and
return the device to STANDBY mode.
- The ADVATx is only intended to be operated by clinicians with
the required clinical knowledge to perform dermatological laser
treatments and the required product training.
- Do not use the ADVATx on or in the vicinity of combustible
materials.
- When using the scanner, ensure and check that the green
aiming beam is visible before starting treatment.

OPERATOR MANUAL PAGE 55

 - Everybody in the room MUST wear the appropriate protective
eyewear.

7.12. Sleep mode

The operator can set the ADVATx into SLEEP mode by pressing the “Sleep”
button. When in SLEEP mode, the ADVATx powers down, but does not turn
OFF. This will reduce sound and heat generation from the ADVATx, but
demand time for the ADVATx to warm up when the “Wake Up” button is
pressed.

SLEEP mode button

Press to set the ADVATx into SLEEP mode.

Wake up from SLEEP mode button

Press to wake up the ADVATx from SLEEP
mode.

It is recommended to set the ADVATx into SLEEP mode instead of turning it

OFF when it is expected to be used again shortly. The wake-up time is
significantly shorter than the initial boot-time for the ADVATx.

If the ADVATx is left unused for 30 minutes, it will automatically be set into
SLEEP mode.

OPERATOR MANUAL PAGE 56

7.13. ADVANCED operating mode
For the experienced operator, the option of choosing the wavelength
directly and adjusting the settings manually, is available.

In ADVANCED operating mode, the Setting screen is neutral, and the

operator must set all parameters manually required to perform the specific
treatment. Choosing skin type is not required in ADVANCED operating
mode.
The preset protocols terminology described in section 7.5 not in use when
using ADVANCED operating mode.
All treatment parameters are in ADVANCED operating mode set and
adjusted as described in section 7.8 to 7.10.

7.14. Turn the ADVATx OFF

The ADVATx is turned OFF by toggling the mains power switch from “I” to
“O”. Refer to section 6.5 for details.
The ADVATx can safely be turned OFF in all modes of operation.

OPERATOR MANUAL PAGE 57

8. Equipment modifications and Error Codes

8.1. Equipment modifications

Do not attempt to service or modify the ADVATx or its accessories. This will
make the ADVATx unsafe and potentially become a risk to the operator
and/or the patient.

WARNING!
No modification of the ADVATx s or its accessories is allowed.

8.2. State information and Error codes

The ADVATx continuously communicates its state of operation to the
operator. E.g. “In sleep mode”, “Applicator not connected”, or if an error
should occur.

The ADVATx is in SLEEP

mode.

The scanner is not

connected.

OPERATOR MANUAL PAGE 58

As soon as the error has been cleared, the ADVATx will revert to STANDBY
mode.
Typical information and error messages are listed below.

Headline Message Ref.

Please wait System initializing

Applicator not connected Please connect an applicator

EMERGENCY STOP Please release the emergency stop

button and restart the system

System too hot Please leave the system in sleep and 8.2.1
wait for it to cool down

System too cold Please wait for the system to warm up. 8.2.2

Safety interlock activated Please check interlock connector

Safety key not activated Safety key is missing or not turned

Foot switch missing or Please connect foot switch or dummy

faulty plug.

In sleep mode Push Wake Up to resume

Please Call Service System Error #X

8.2.1. ERROR - System too hot

The ADVATx is too hot and needs time to acclimatize. The internal
temperature of the ADVATx must not exceed 55 °C (131 °F). Set the ADVATx
into SLEEP mode, reduce the room temperature and ensure, that the
ADVATx has sufficient free air to cool.
8.2.2. ERROR - System too cold
The ADVATx is too cold and needs time to acclimatize. The internal
temperature of the ADVATx must be above 15 °C (59 °F) for the system to
operate.

OPERATOR MANUAL PAGE 59

9. Applied parts & accessories
The list below provides a complete overview over accessories included and
available for the ADVATx.

Description Art. No
Operator Manual, US 1503
Scanner (Type BF) 1444
Mains power cord, DK IEC 320, Type K 800
Mains power cord, Schuko IEC 320, Type F 799
Mains power cord, US IEC 320, Type B 846
Mains power cord, UK IEC 320, Type G 1540
Mains power cord, India IEC 320, Type D 1670
Interlock dummy plug 1221 A
1344 B
Key for key switch 473
Foot switch 780 A
1448 B
Foot switch dummy plug 1458 B
Safety eyewear, 589 nm OD5+, fit-over 761
Safety eyewear, 589 nm OD5+, slim-fit 1318
Safety eyewear, 1319 nm OD7+, fit-over 913
Patient safety eyewear (aluminum) 995
Scanner Distance Piece 7/8 circle 576
Scanner Distance Piece 1/2 circle 1193
Scanner Distance Piece 1/8 circle 1306
Scanner Distance Piece with sapphire window 1663
Fuses - Ø5x20 mm F6.3AL250V 735
Bottom air inlet replacement filter 1529 B

A For ADVATx systems with serial number 1xxxxx

B For ADVATx systems with serial number 2xxxxx

OPERATOR MANUAL PAGE 60

WARNING!
The scanner can only be repaired and serviced by authorized and
manufacturer trained field service engineers.
Use of non-Advalight approved accessories may negatively affect the
EMC performance.

OPERATOR MANUAL PAGE 61

10. Technical Specifications

10.1. Output power

The ADVATx constantly optimized the output power of the laser module.
This ensures, that the treatment time with operator set fluence is kept as
short as possible.

10.2. Fluence
The fluence is the energy delivered per area. Fluence is measured in joules
per square centimeter J/cm2.
As the ADVATx delivers a constant output of light/energy and the scanner
spot size is constant 1 mm, the fluence is adjusted as a function of time. The
higher fluence set by the operator the longer the resulting treatment time.
The ADVATx has a built in fluence limit.
- 589 nm 60 J/cm2
- 1319 nm 60 J/cm2 None US limit
- 1319 nm 40 J/cm2 US limit, FDA defined

10.3. Biological evaluations

Biological evaluations the scanners components in patient and operator
contact have been conducted.
Cytotoxicity, sensitivity, irritation and intracutaneous reactivity has been
assessed and conclude as remote for both patient and operator.

10.4. Specifications
ADVATx Specifications
Laser Type Nd:YAG
Laser Class 4 EN 60825-1:2007
Electrical Safety Class 1 EN 60601-1:2016
Wavelengths 589 nm & 1319 nm
Scanner – type BF Up to 10x10 mm area
1 mm spot diameter
Pulse Width 589 nm: 20 – 950 ms
1319 nm: 20 – 200 ms
Fluence 589 nm Min: 5 J/cm2
Max: 60 J/cm2
Fluence 1319 nm Min: 5 J/cm2

OPERATOR MANUAL PAGE 62

ADVATx Specifications
Max: 40 or 60 J/cm2, set by regional settings
Scanner beam 150 mrad
divergence
Scanner NOHD 64.8 cm (25.2”)
Nominal Optical
Hazard Distance
MPE 33 mJ/m2
Maximum permissible
exposure
Power Supply 120 – 240 V, 50/60 Hz
Power consumption Max. 900 VA
Fuses 2 pcs. F6.3AL250V, Ø5x20 mm
Size (HxWxD) 133 x 56 x 56 cm (52” x 22” x 22”)
Weight Approx. 80 kg (176 lbs.)
Internal laser unit Forced air
cooling
Protection against Class IPX0
ingress of water
Pulse control Foot pedal and/or scanner trigger switch
Consumables None
Operating humidity A humidity less than 80% noncondensing is
required
Operating 18 – 27 °C (64 – 81 °F)
temperature
Operating altitude 0 – 2000 m
Operating 80 – 150 kPa
atmospheric pressure
Operating pollution 2
degree
Patient leakage Max: 200 µA
current
Earth leakage current Max: 500 µA
Expected lifetime 7 years

OPERATOR MANUAL PAGE 63

10.5. Storing and transportation
The ADVATx should be stored and transported under controlled conditions:

- Temperature: 0 – 50 °C (32 – 122 °F)

- Humidity: 20 – 90% (at 30 °C not condensing)
- Atmospheric pressure: 80 – 150 kPa

- Max pollution degree: 2

It is recommended to unplug the ADVATx from the power grid if it is not
used over a longer period of time.

If transported, the original ADVATx shipping case must be used to protect

the system the best possible way. An ADVATx shipping case can be obtained
by contacting the local ADVATx distributor.

Packaging label attached the

shipment box

OPERATOR MANUAL PAGE 64

 Example of ADVATx shipment
box.

The ADVATx must stay in the shipment box throughout the entire shipment.

OPERATOR MANUAL PAGE 65

10.6. Service
The ADVATx must be serviced once a year to ensure full functionality,
performance and safety.
Failure to have the ADVATx serviced, may impact its safety, warranty and
performance.
Service of the ADVATx must be conducted by an authorized service
engineer.
In the event of malfunction or fault please contact an authorized
distributor. Information as how to contact the nearest authorized
distributor can be found on: www.advalight.com.
10.6.1. Air inlet filter replacement
It is recommended, that the user replaces the bottom air inlet Art. No.:
1529 filter on a quarterly basis. This ensure, that the ADVATx cooling
capacity is maintained at the highest level.
Turn OFF the ADVATx and detach the mains power cord.

Unscrew the two thumbscrews

situated below the white cover plate
on the ADVATx cabinet rear side.

Pull out the filter box.

OPERATOR MANUAL PAGE 66

Pull the old filter material off from
the filter box.

Remove as much of the residual filter

material from Velcro® lining on the
filter box edges.

Apply the new filter material ensuring

a nice fit along the edges of the filter
box.

OPERATOR MANUAL PAGE 67

Firmly press the new filter material
onto the Velcro® lining on all filter box
edges.

Reinsert the filter box and tighten the

thumbscrews.

OPERATOR MANUAL PAGE 68

10.7. Disposal
The lifetime of the ADVATx will depend on usage, maintenance, exposure to
temperature swings, cleanliness of surrounding environment, etc. If taken
care of well the ADVATx will last for many years.
Disposal of the ADVATx must be handled according to the international
WEEE directive (Waste Electrical and Electronic Equipment). If the owner
does not want to carry out this task, the ADVATx can be returned to the
manufacturer.

IMPORTANT!
The owner must contact the manufacturer prior to returning the
ADVATx to ensure that the disposal responsibility is transferred to the
manufacturer correctly.

10.8. Warranty Terms and Conditions

The ADVATx comes with a warranty that complies with national regulations.
Potentially an extended warranty has been agreed on with the national
distributor e.g. as part of a service contract.
Unless national regulations or specific explicit agreements states differently,
the warranty does not apply to damaged fibers, cords and wires.

OPERATOR MANUAL PAGE 69

10.9. Guidance and manufacturer’s declaration – EMC topics
The ADVATx is tested and complies to IEC 60601-1-2:2015.
The ADVATx is intended for use in the electromagnetic environment
specified below. The customer or the user of the system should assure that
it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions tests Compliance Electromagnetic environment
Radiated emission Class B The ADVATx uses RF energy only for its internal
EN 55011:2009 + A1 Group 1 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
(CISPR 11)
nearby electronic equipment.
Conducted emission Class B
The ADVATx is suitable for use in all establishments,
EN 55011:2009 + A1 Group 1 including domestic establishments and those directly
(CISPR 11) connected to the public low-voltage power supply
network that supplies buildings used for domestic
Harmonic current emissions Class A
purposes.
IEC 61000-3-2:2014
Voltage fluctuations and flicker Complies
IEC 61000-3-3:2013

Guidance and manufacturer’s declaration – electromagnetic immunity

Electromagnetic
Immunity tests EN 60601 Test level Compliance level
environment
Electrostatic discharge ± 8kV contact ± 8kV contact Floors should be wood,
IEC 61000-4-2:2009 ± 2, 4, 8, 15kV air ± 2, 4, 8, 15kV air concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30% RH.
Fast transients ± 2kV at 100kHz for ± 2kV at 100kHz for Mains power quality
IEC 61000-4-4:2012 power supply lines power supply lines should be that of a
typical commercial or
hospital environment.
± 1kV at 100kHz for ± 1kV at 100kHz for
input/output lines input/output lines
Surge +/-0.5, 1,2kV at 0, 90, +/-0.5, 1,2kV at 0, 90, Mains power quality
IEC 61000-4-5:2014 180, 270° AC mains line 180, 270° AC mains line should be that of a
to ground to ground typical commercial or
hospital environment.
+/-0.5, 1kV at 0, 90, 180, +/-0.5, 1kV at 0, 90,
270° AC mains line to 180, 270° AC mains line
line to line
Voltage dips, short 0% UT, 0.5 cycle at 0, 45, 0% UT, 0.5 cycle at 0, Mains power quality
interruptions and 90, 135, 180, 225, 270 45, 90, 135, 180, 225, should be that of a
voltage variations and 315° 270 and 315° typical commercial or
IEC 61000-4-11:2004 hospital environment. If
the user of the ADVATx
0% UT, 1 cycle at 0° 0% UT, 1 cycle at 0°
requires continued
operation during mains
70% UT, 25/30 cycles at 70% UT, 25/30 cycles at power interruptions, it is
0° 0° recommended that the
system is powered from
an uninterruptible power
0% UT, 250 cycles at 0° 0% UT, 250 cycles at 0°
supply or a battery.

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Guidance and manufacturer’s declaration – electromagnetic immunity
Electromagnetic
Immunity tests EN 60601 Test level Compliance level
environment

Power frequency 30 A/m 30 A/m Power frequency

magnetic field (50/60Hz) 100% dip, 0.5 cycle at 0, 100% dip, 0.5 cycle at magnetic fields should
IEC 61000-4-8:2009 45, 90, 135, 180, 225, 0, 45, 90, 135, 180, be at levels characteristic
270 and 315° 225, 270 and 315° of a typical location in a
typical commercial or
hospital environment.
NOTE: UT is the AC mains power voltage prior to application of the test level.

Electromagnetic
Immunity test EN 60601 Test level Compliance level
environment
RF conducted 3Vrms 3Vrms Portable and mobile RF
IEC 61000-4-6:2014 6Vrms at ISM bands 6Vrms at ISM bands communications
equipment should be used
150kHz to 80MHz
no closer to any part of the
ADVATx, including cables,
than the recommended
RF Radiated 3V/m 3V/m separation distance
calculated from the
IEC 61000-4-3:2006 80MHz to 2.7GHz
equation applicable to the
+ A1 & A2 frequency of the
transmitter.

Proximity fields from RF 80MHz to 6GHz 9V/m to 28V/m Field strengths from fixed
wireless RF transmitters, as
communications determined by an
equipment electromagnetic site
IEC 61000-4-3:2006 surveya, should be less
than the compliance level
+ A1 & A2
in each frequency rangeb.

Interference may occur in

the vicinity of equipment
marked with the following
symbol:

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the ADVATx is used exceeds the applicable RF compliance level above, the ADVATx should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the ADVATx.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

OPERATOR MANUAL PAGE 71

Recommended separation distances between portable and mobile RF communications equipment and the
ADVATx
The ADVATx is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the ADVATx can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the ADVATx as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output Separation distance according to frequency of transmitter in meters
power of transmitter in 150kHz to 80MHz 80MHz to 800MHz 800MHz to 6GHz
watts

𝒅𝒅 = 𝟏𝟏. 𝟐𝟐√𝑷𝑷 𝒅𝒅 = 𝟏𝟏. 𝟐𝟐√𝑷𝑷 𝒅𝒅 = 𝟐𝟐. 𝟑𝟑√𝑷𝑷

0.01W 0.12m 0.12m 0.23m

0.1W 0.38m 0.38m 0.73m
1W 1.2m 1.2m 2.3m
10W 3.8m 3.8m 7.3m
100W 12m 12m 23m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters [m] can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.

NOTE 1: At 80MHz and 800MHz the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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11. APPENDIX A – Declaration of Conformity

OPERATOR MANUAL PAGE 73