My-Doc DocLaser Sport User manual

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QUICK REFERENCE GUIDE
λ= 810 nm
P= 2 Watt
INSTRUCTIONS FOR USE
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YOUR
PERSONAL
TREATMENT

2

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Project management:
Medical Treatment and Protocols Dr. Pier Francesco Parra
Design and Development Ing. Giannino Algeri

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INDEX
OVERVIEW .............................................................................................................06
CONTROLS AND INTERFACE.........................................................................07
DESCRIPTION OF ITEMS..................................................................................08
THE DISPLAY........................................................................................................09
CONTROL KEYS...................................................................................................09
INSERTING THE PASSWORD .........................................................................09
ASSISTANCE AND ADVICE .............................................................................10
TECHNICAL DATA: EXTERNAL POWER SUPPLY....................................11
TECHNICAL DATA: AG6 LASER MODEL DOCLASER® SPORT .........11
INSTRUCTIONS FOR DISPOSAL ...................................................................11
PROCEDURE FOR USE ....................................................................................12
CHANGE LANGUAGE AND RESTORE FACTORY CONFIGURATION .13
TREATMENT..........................................................................................................14
CHECKING CORRECT OPERATION OF CONTACT SENSORS..............17
VERIFYING THE INTENSITY (2 WATTS) OF EMITTED POWER................18
OVERVIEW OF TREATMENT MANAGEMENT ..........................................19
TREATMENT AFTER THE FIRST SESSION................................................20
NOTES ON PROTOCOL MANAGEMENT......................................................21

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MANAGEMENT AND CONTROL OFPROTOCOLS WHEN RESULTSPRESENT
A SIGNIFICANT DIFFERENCE WITH RESPECT TO THE ESTABLISHED
MATHEMATICAL MODEL .....................................................................................22
MANAGEMENT OF MEMORY SPACE...........................................................23
MANAGEMENT OF ALARM MESSAGES ....................................................24
GENERAL RULES FOR CORRECT USE.......................................................25
ARCHITECTURE OF THE EXCLUSIVE DOCLASER® PROTOCOL
(NOTES) ...................................................................................................................26

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OVERVIEW
DOC LASER® is a Class-IV laser device, certied and classied as a medical instrument
in Class 2b (93/42/EEC, 47/2007EEC). It differs from normal therapeutic laser instruments
as it is designed to provide for ‘self-administered treatment’. The software installed is
of the interactive type; by means of step-by-step procedures, the program will assist
users, who must carefully follow the sequence of instructions that appear on the screen.
Please note that it is very important to read and review the content of the enclosed
manual (CD) before using this device.
DOCLASER® SPORT must not be used in the following situations:
CONTRAINDICATIONS
Suspected or fully-developed neoplasia, pregnancy, haemorrhagic
areas, epilepsy, infected areas (contaminated, open wounds), herpes
zoster / herpes simplex, general states of infection, children under
the age of 16, direct exposure to the eyes.
N.B.: no particular precaution is required during treatment in the
case of persons with prostheses or a pacemaker or in the case of diabetes.
It should be noted that for all persons who have received radio or chemotherapy ANY
PHYSICAL THERAPY IS CONTRAINDICATED FOR A PERIOD OF 5 YEARS FOLLOWING
THE LAST SESSION OF TREATMENT.
ORDINARY MAINTENANCE
“DOCLASER® SPORT” must be stored in its case, protected against sources of intense
heat (e.g. solar rays). It must not be kept in an environment where temperatures will
remain low (< 10°C) for long periods of time (e.g. during the night). Failure to respect this
condition will immediately result in the laser not being usable.
The protective glass cover must be kept clean at all times, ensuring that it does not
become soiled in any way with traces of grime or dirt in general. A camera/lens
microbre cloth should be used to clean the glass cover. Do not use detergents, except
for isopropyl alcohol. The circular head, which comes into contact with the skin during
treatment, must also be cleaned. Isopropyl alcohol should be used also in this case.
Anti-reex glass cover
Contact sensor for laser emission control

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CONTROLS AND INTERFACE
Display
Extractable fuse switch
disconnector
Socket for
battery-charger
jack plug
Charge indicator (LED)
Emergency stop button
Ventilation slots
Laser beamer
Interactive controls
Switch on/off

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DESCRIPTION OF ITEMS
Ventilation slots. These spaces allow for thermal exchange between the internal heat
spreader and the environment thanks to the convective movement of air. The slots must
be kept free at all times; make sure they are never obstructed by any kind of adhesive
or other material.
Emergency switch: in the event of breakdown or faulty operation, with the resulting
potential loss of safe operating conditions, the operator has the possibility of using
an emergency control, which will ensure the laser source is switched off. Following
conrmation provided by means of an acoustic, maximum-frequency signal, DOC
LASER will switch off automatically.
Extractable fuse switch disconnector: This component has a double function and
represents an ultimate form of protection for the lithium battery against short-circuiting.
Acting as a sectioning separator of mains power from the rest of the device, it is used in
only two situations:
• when it is envisaged that Doc laser will not be used for at least two years;
• when Doc Laser responds to none of the commands (including the emergency switch).
In this case the operation required will be a full reset; when restored, all previously-
saved data will be lost.
Battery-charger LED: when the power feeder is connected to the battery properly and
the battery is discharged, the (yellow) LED will be switched on.
Socket for battery-charger jack plug: Insert the battery-charger jack provided with the
laser device to recharge. Note: it is not possible to use the Doc Laser device for treatment
during recharging phases. Time required for complete recharging: < 3 hrs.
Laser beamer:
• the base , and also the rest surface which has to ‘touch’ the user’s skin contains the
four contact sensors that enable the emission of laser radiation;
• the laser diode window is protected by an anti-reex glass cover and is the part
subject to most attention on the part of the operator; keep the glass clean at all times (cfr.
Instructions for Use – maintenance section) and perfectly transparent, with no traces of
grime, grease, dust or other substances.

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THE DISPLAY
High-denition display. Various interactive screen pages
appear, presenting options for the selection of procedures
and conrmation and messages referring to reviews of the
progress of selected treatment protocols and an evaluation of
the success of results obtained.
The surface of the screen should be cleaned with micro-bre
cloth (camera/lens cleaning material); in any case avoid using
metallic or pointed objects.
CONTROL KEYS
INSERTING THE PASSWORD
In the phase in which operation is enabled only the directional keys are used; if the
password is correct, the device will allow access to the following pages.
Up key (directional key only): scrolls upwards only.
Right key: active only when a password is being inserted.
Left key: when active, returns the user to the pages to
repeat the ongoing procedure.
Down key (directional key only): scrolls downwards only.
OK/ON/OFF key: this key is used to switch the laser device on but it is also used during
operation as a ‘conrm/accept’ key (like the ‘return’ key on a computer keyboard);
to switch off the laser device press this key until a ‘beep’ is heard, indicating that the
‘switch-off’ command has been activated.

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ASSISTANCE AND ADVICE
If one of the following windows appears on the screen of your DOC LASER device
while it is being used, please consult the User Manual. If the restore operation
fails and a solution cannot be found, forward an e-mail message to our technical
department [e-mail]. Our staff will promptly answer any questions
you may have.
Make sure the temperature of your laser device is not
excessively high or too low. If it has been exposed for a long
period to sources of heat or inversely, to low temperatures,
this will be the most likely cause.
In such cases the device must be removed to an environment
where the temperature is approximately 20-26°C. Wait until
it automatically returns to normal operating conditions
(normally, 20-30 minutes).
Repeat the test using the palm of your hand. If still
unsuccessful, contact technical our assistance personnel.
Repeat the test with the palm of the hand, totally covering
the emission window, after checking that the protective glass
is perfectly clean. If the operation fails again, contact our
assistance service.
CONTROLLO A LLARMI
ANOMALIA
per r i s olverl a
consulta
il manua l e d’us o
TEMPER AT URA
TESTA L ASER
LASER HEAD
TEMPERATURE
ANOMALY
refer to user
manual
ALARM CHECK
CONTROLLO A LLARMI
ANOMALIA
per r i s olverl a
consulta
il manua l e d’us o
SENSORI D I
C O N TAT T O
CONTACT
SENSORS
ANOMALY
refer to user
manual
ALARM CHECK
CONTROLLO A LLARMI
ANOMALIA
per r i s olverl a
consulta
il manua l e d’us o
ERRO R E EMISSION E
L A SER
LASER EMISSION
ERROR
ANOMALY
refer to user
manual
ALARM CHECK

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TECHNICAL DATA: LASER MODEL AG6 DOCLASER® SPORT
Rated power (Pnom) - IEC EN 60825-1 up to 2 W (*)
Spot size with applicator in contact 10 mm
Wavelength 630 - 1064 nm
Beam divergence 8° x 36°
Power density with applicator up to 1.4 W/cm2 max
Operation discontinuous
INSTRUCTIONS FOR DISPOSAL
This symbol, appearing on the device and its outer packaging, refers to the
disposal procedure to be adopted when it is decided the instrument should
be discarded. When the instrument is no longer needed and has reached the
end of its working life, it should not be disposed of just like any other waste
product but delivered to a differentiated refuse collection site for electronic
equipment or simply returned to the retailer from whom it was purchased
when a new laser source has to be purchased.
TECHNICAL DATA: EXTERNAL POWER SUPPLY
Frequency: 47 – 63 Hz
Input voltage: 90 – 264 Vac (wide range)
Output voltage: 5.0 V
Maximum power: 10 W
Operating temperature: 0° / + 40°C
Humidity: 5% - 95% RH
non-condensing

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PROCEDURE FOR USE
1. Switch on the device by pressing the ‘OK’ key for about 5 seconds
2. At the rst start-up select language
3. Wait until the software asks you to insert the password
4. Insert the password (sequence of 4 keys)
The operator must carefully follow all details and instructions that appear on the display.
Proceed in accordance with the sequence
The simple clear language of the software allows for immediate comprehension of the
messages and instructions.
The step-by-step instructions can be easily understood by users that have absolutely no
previous experience with medical equipment of this kind.
SELECT LANGUAGE
CANCEL
ITALIANO
ENGLISH
PASSWORD
OK
Sequence requested as a password
Up Down Left Right

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CHANGE LANGUAGE AND RESTORE FACTORY CONFIGURATION
It is possible come back to language selection inserting, during the DOCLASER®SPORT
password request, the following sequence:
It is possible to reinstate DOCLASER®SPORT to factory conguration inserting, during
the password request, the following keys sequence: Be carefull, this action will reset all
settings and memories:
PASSWORD
OK
PASSWORD
OK
SELECT LANGUAGE
CANCEL
ITALIANO
ENGLISH
Sequence requested as a password
Up DownLeft Right
VUOI RIPRISTINARE
LA CONFIGURAZIONE
DI FABBRICA?
SI
NO
YES
NO
DO YOU WANT TO RESET TO THE
DEFAULT CONFIGURATION?
Sequence requested as a password
UpDown LeftRight
The battery capacity allows for storage for up to 2 years without any need to recharge.
The device will start at the rst touch of the controls and will be ready for use.
More in-depth information is available in the Compact Disk supplied with the laser
device.

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TREATMENTS
Your DOCLASER® SPORT device contains 30 treatment protocols, 8 of which are not
directly associated with pain presenting in specic anatomical areas, 3 of which refer to
physical problems arising in various parts of the body and 3 protocols (very important
and to be adopted only under the guidance of a physician) are proposed for one of the
very special benets produced by laser tissue bio-stimulation: pain-reduction, an anti-
inammatory effect and decontraction.
The other treatment options will follow. If the operator adheres strictly to the
contraindications listed on page 6, the worst result obtained will be simply an absence
of positive results. In such cases messages will appear referring to the lack of results
obtained within the expected time and suggesting that the user should abandon the
procedure in question.
n.b.: users will select a protocol,
mainly considering the type of
pain to be treated.
Please note that medical
guidance is necessary. This will
be less important only in cases
of chronic pain or conrmed
cases: of traumatic origin or
functional muscular-tendinous
and/or osteo-articulatory
overloading.
SCEGLI L’AREA SPECIFICA
ALTRE OPZIONI
1
2
3
4
IDENTIFY THE SPECIFIC AREA
OTHER OPTIONS
1
2
3
4
SCEGLI AREA SPECIFICA
TENDINOPATIA
DEL SOVRASPINOSO
IMPINGEMENT DEL
BICIPITE DEL CAPOLUNGO
TENDINOPATIA
DEL SOTTOSPINOSO
SPALLA DOLOROSA
CON BORSITE
SOTTOACROMIALE
SELECT SPECIFIC AREASELECT SPECIFIC AREA
SUPRASPINATUS
TENDINOPATHY
LONG HEAD
BICEPS IMPINGEMENT
INFRASPINATUS
TENDINOPATHY
SHOULDER PAIN
WITH SUBACROMIAL
BURSITIS
SELECT SPECIFIC AREA
TENDINOPATIA
ROTULEA
TENDINOPATIA
DELLA ZAMPA D’OCA
MENISCO DOLOROSO
LATERALE
MENISCO DOLOROSO
MEDIALE
LATERAL
PAINFUL MENISCUS
PATELLAR
TENDINOPATHY
ANSERINE
TENDINOPATHY
MEDIAL
PAINFUL MENISCUS
SCELTA DELL’AREA SPECIFICA
SINDROME DEL
TUNNEL CARPALE
ARTROSI ALLA
BASE DEL POLLICE
ARTROSI DELLA MANO
SINDROME DEL
TUNNEL CARPALE
ARTROSI ALLA
BASE DEL POLLICE
ARTROSI DELLA MANO
SINDROME DEL
TUNNEL CARPALE
TENDINOPATIA
DELL’ESTENSORE
DEL POLLICE
DISTORSIONE DEL POLSO
SELECT SPECIFIC AREA
ARTROSI ALLA
BASE DEL POLLICE
ARTROSI DELLA MANO
ARTROSI ALLA
BASE DEL POLLICE
ARTROSI DELLA MANO
THUMB EXTENSOR
TENDINOPATHY
WRIST DISTORTION
CARPAL-TUNNEL
SYNDROME
SCEGLI L’AREA SPECIFICA
DISTORSIONE
DELLA CAVIGLIA
TENDINOPATIA ACHILLEA
FASCITE PLANTARE
SELECT SPECIFIC AREA
SPRAINED
ANKLE
ACHILLEA TENDINOPATHY
PLANTAR FASCIITIS

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The operator is asked to conrm the painful area selected. If an anatomical area cannot
be found, it is possible to repeat the search if necessary. At the third attempt (second
repetition) the software will automatically activate the switching-off procedure.
EMATOMA
SOTTO-CUTANEO
GINOCCHIO E
CAVIGLIA GONFI
STIRAMENTO
MUSCOLARE
SCELTA AREA SPECIFICA
ALTRE OPZIONI
SUBCUTANEOUS
HAEMATOMA
SWOLLEN KNEE
AND ANKLE
SELECT SPECIFIC AREA
OTHER OPTIONS
MUSCOLAR PULL
SCELTA AREA SPECIFICASCELTA AREA SPECIFICA
SINDROME DELLE
FACCETTE ARTICOLARI
LOMBALGIA SENZA
SEGNI RADICOLARI
SINDROME DEL PIRIFORME
SELECT SPECIFIC AREA
FACET JOINT
SYNDROME
LOW BACK PAIN WITHOUT
RADICULAR SIGNS
PIRIFORMIS SYNDROME
ANTI INFIAMMATORIO
ANTALGICO
DECONTRATTURANTE
SCEGLI IL TRATTAMENTO
ALTRE OPZIONI
ANTI-INFLAMMATORY
ANTALGIC
DECONTRACTION
SELECT THE TREATMENT
OTHER OPTIONS
SCEGLI L’AREA SPECIFICA
ALTRE OPZIONI
1
2
3
4
IDENTIFY THE SPECIFIC AREA
OTHER OPTIONS
1
2
3
4
EMATOMA
SOTTO-CUTANEO
AREA SPECIFICA
OK
CONFIRM YOUR CHOICE
SPECIFIC AREA
SUB-CUTANEOUS
HAEMATOMA
SCELTA AREA SPECIFICA
DOLORI DORSALI
MIOFASCIALI
DOLORE ESTESO DAL
COLLO ALLE SCAPOLE
DOLORE FISSO E PUNTIFORME
NELLAZONA DELLASCAPOLA
SELECT SPECIFIC AREA
MYOFASCIAL
BACK PAIN
PAIN EXTENDING FROM
THE NECK TO THE
SHOULDER BLADES
CONSTANT AND
PUNCTIFORM PAIN IN THE
SHOULDER-BLADE AREA

16
SCEGLI L’AREA SPECIFICA
ALTRE OPZIONI
1
2
3
4
IDENTIFY THE SPECIFIC AREA
OTHER OPTIONS
1
2
3
4
CLASSIFY YOUR PAIN
VERY INTENSE
INTENSE
MODERATE
SLIGHT
MINIMAL
NON HA IL A
CHE SERVE AL TUO CASO
YES
NO
MAYBE
DOESN’T HAVE THE
PROGRAM YOU NEED
DO YOU WANT TO CONTINUE
AND SEARCH AGAIN FOR A
TREATMENT PROTOCOL?
non ha effetti
ionizzanti e le
tecnologie
utilizzate
garantiscono la
massima
sicurezza
RADIAZIONI
IONIZZANTI
has no ionizing
effects ant the
technology
used ensures
maximum
safety
IONIZING
RADIATION
Finally, the operator is
asked to identify the
intensity of the pain
according to the visual
analogue scale (VAS). The
data summary page will
now appear, indicating the
painful area selected and
pain intensity.
Conrmation is then
requested.
IS THE FIRST REPETITION?
YES
NO
CONFIRM YOUR CHOICE
VERY INTENSE PAIN
FRONT SHOULDER PAIN
OK
YES

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CHECKING CORRECT OPERATION OF THE CONTACT SENSORS
Operation logic: (considered also for risk analysis): laser emission is enabled only when
the devices switches from 4 red sectors to 3 or 4 green sectors or 2 sectors ( minimum
condition to enable operation)) on the longer side of the emission window. The device
allows for use without protective eyewear. In any case correct operation should be tested
before each treatment session.
Contact sensor management, phase 1: checking for correct operation compulsory!
SEQUENCE to be followed to test correct functioning of the 4 contact sensor sectors:
“Contact sensor check”
1. Laser not in contact with the palm of the hand. The operator must make sure that
the 4 sectors are red (inactive).
2. Laser in contact. The operator will move the laser in an appropriate manner so as
to make contact with the skin and must make sure the 4 sectors are activated (they
will change colour, depending on the moment)
3. Successful outcome of verication. The 4 sectors must be green.
The message ‘OK, Start Treatment’ will automatically appear only after the correct
switching of all sectors has been veried by the software. If the test is not successful after
7 seconds, the ‘procedure-repetition’ function will be enabled. The software will allow
the user to run the test three times before automatically providing an error message
(faulty operation) and suggesting the intervention of a technical support centre.
CHECK CONTACT SENSOR
bring the active part
of the laser into contact
with the palm of your hand
LASER
CHECK CONTACT SENSOR
bring the active part of the laser
into contact with the palm
of your hand
LASER
OK
START TREATMENT
N.B.: The contact sensor test
must be successfully
completed before starting
treatment. Simply rest
the laser emission point on the
palm of the hand and
check for correct switching
(‘on’ / off’) of all four sectors.

18
VERIFYING THE INTENSITY (2W) OF EMITTED POWER
After verifying that the contact sensors are functioning
properly, the power emitted by the laser will checked. In
order to measure maximum power safely rest the emitter
on the palm of the hand. With the contact sensors closed,
emission is enabled.
The operators provides conrmation with the OK key.
The procedure consists in having the laser source initiate
emission at the maximum power level (P=2W) and then
measuring it with an internal system, making sure the
deviation falls within the range permitted by the standards
(± 20%).
Se la verica ha avuto esito positivo la scritta “test in corso”
si trasforma in “OK Emissione corretta” e l’operatore può
iniziare il trattamento in tutta sicurezza.
Bring the active part of
the laser into contact
with the palm of your
hand. maintain contact
until the end of the test
which will last about 1
minute.
press OK to start the test.
CHECK LASER EMISSION
OK
CHECK EMISSIONE LASER
Mantieni la parte attiva
del laser a contatto con
il palmo della mano sino
al termine del test.
TEST IN CORSO
CHECK LASER EMISSION
TEST IN PROGRESS
maintain the active part
of the laser in contact
with the palm of your
hand until the end of the
test
CHECK EMISSIONE LASER
Mantieni la parte attiva
del laser a contatto con
il palmo della mano sino
al termine del test.
OK
EMISSIONE CORRETTA
CHECK LASER EMISSION
OK
CORRECT EMISSION
maintain the active part
of the laser in contact
with the palm of your
hand until the end of the
test

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OVERVIEW OF TREATMENT MANAGEMENT
The operator is asked to position the emitter correctly over the painful area within the
indicated area. Press ‘OK’ when ready to proceed.
No comments are provided for energy-transfer and treatment-recording phases. Note
that in the initial sessions the operator may decide where and how treatment data is
going to be saved.
N.B. If the area to be treated presents an excessively concave or convex surface, thereby
making it difcult to obtain minimum and sufcient contact to enable the laser, the user
should identify and retain the best position possible.
The ‘scattering’ effect will ensure the laser reaches underlying tissues.
A light rotating movement can be attempted if it is found that the skin is subject to
excessive heat.
Also for the treatment of small surface areas (e.g. nger interphalangeal articulation)
the laser should be kept focused.
punto doloroso. Se
posizionare il laser al
suo interno.
TREATMENT INSTRUCTIONS
Observe the area to be
treated. Position the
laser on painful area. If
specified, position the
laser inside the
highlighted area.
TREATMENT ISTRUCTIONS
OK

20
TREATMENT AFTER THE FIRST SESSION
At the beginning of each day of therapy the operator is
reminded of the number of repetitions of the treatment
protocol established on the basis of a patented My-Doc
algorithm. If the user does not follow the preset protocol
or number of sessions, messages referring to the anomaly
in question will be generated by the software; if necessary,
records of treatment sessions already completed will
be deleted and the user is then invited to start from the
beginning. Transfer with repeated micro-sessions and multi-
treatment protocols are a natural evolution of the principles
of optimisation and an extension of the biostimulation effect
invented by Prof. Parra with the FP3 SYSTEM® project.
STAI SEGUENDO IL
TRATTAMENTO NUMERO
INIZIA IL TRATTAMENTO
1 / 2
ULTIMO
OK
START TREATMENT
1 / 2
LAST
OK
YOU ARE FOLLOWING
TREATMENT NUMBER