Lasermed

Lasermed
4098

User Manual

4098

Summary

02 .............Presentation
02 .............Equipment Accessories
03 .............General Information
06 .............Symbols
07 .............Warning
08 .............Installation/ Grid Connection
09 .............Display Languages
10 .............Functions of controls
12 .............Laser Probes
16 .............Modes of operation
16 .............Device Operation
18 .............Mode: Energy Therapy
19 .............Mode: Nogier Therapy
21 .............Mode: Free Therapy
22 .............Protocols
26 .............Operation of the toposcopic pen
27 .............Types of applications
27 .............Master Control Key and Remote Interlock Connector
28 .............Indications
31 .............Contraindications
31 .............Preventive maintenance and preservation
33 .............Safety Warning
34 .............Corrective maintenance
35 .............Technical features
37 .............Declarations
43 .............Final considerations
42 ..European Representative
42 .............Bibliographical references

English
Revision: 05
MU_LASERMED_4098_ENG_Rev.05_092009

Lasermed

4098

Lasermed

4098

Presentation

General Information

Carci is proud to congratulate you for the aquisition of a high technology and
security equipment. Where we are sure this equipment will satisfy the
highest quality standards.

The term LASER means Light Amplification by Stimulated Emission

of Radiation.
This light radiation has unique characteristics, different from
ordinary light, such as:

LASERMED 4098 was designed according to IEC 60601-1:1994 + amend

1:1997, IEC 60601-2-2006, and IEC 60601-2-22:1997 safety rules, which
makes them a safe and reliable product.

Coherence: while ordinary light is made up of several

wavelengths and spatially arranged in disorderly fashion,
laser emission is formed by one wavelength only, bearing
waves coherent between itself, both time wise and spatial
wise;

Polarization: laser radiation is polarized, which allows its

parallelism, which does not occur in ordinary light;

Monochromaticity: due to the existence of only one

wavelength, laser radiation becomes monochromatic.

Equipment Accessories

01
01
01
01
01

Laser Probe 905nm, 20mw (60Watts peak) - pulsed

Laser probe cable
Tripolar power cable
Toposcopic pen
User Manual

The Lasermed 4098 can be supplied with Laser probe in the lenght
of 905nm (infrared) pulsed with 60W of peak, 830nm (infrared) continuous
with 30mW continuous and 650nm (red) continuous with 12mW continuos.

Since laser radiation is made up of photons that transport energy, on

applying laser radiation on any surface, we are transferring Energy.
On applying laser radiation on a tissue, we are transferring a certain
amount of energy. With this energys application, we obtain effects we can
describe as direct (or primary), indirect and therapeutic.

To buy optional accessories, please verify the codes at page 36, Additional
Accessories .
If you have any doubt, please contact:
Technical Assistance Department
Rua lvares Fagundes, 359
So Paulo SP Brasil -CEP 04338-000
Tel.: (0XX11) 5621 7024 / 5622 8205
e-mail : [email protected]

MU_LASERMED_4098_ENG_Rev.05_092009

MU_LASERMED_4098_ENG_Rev.05_092009

Lasermed

below:

4098

The effects of radiation on tissues are represented by the scheme

Lasermed

4098

Figure 1 shows laser radiation absorption by hemoglobin and water:

Radiation Absorbed

Direct Effects or Biochemical Effect

Primary:
Bioelectric Effect
Bioenergetic Effect

Indirect Effects:

Microcirculation stimulation
Cellular trophic stimulation

Therapeutic Effects:

Analgesic
Anti-inflammatory
Anti-edematous
Stimulates tissue trophism

wavelength

Hemoglobin absorbs wavelengths of less than 600 nm, where the

Argon lasers (514 nm, green) are located, and water absorbs wavelengths of
more than 1200 nm, where the CO2 and NdYg lasers are located.

Laser has been used successfully and efficiently in physiotherapy in

the treatment of painful, inflammatory processes, ulcers, joint disorders,
fracture repair and especially in traumatic lesions in sports practice.
Usually, laser therapy uses emitters with wavelengths between 600
nm and 1100 nm (nanometers), since wavelengths of less than 600 nm and
greater than 1100 nm are strongly absorbed by the skin, consequently
reducing penetration depth.

MU_LASERMED_4098_ENG_Rev.05_092009

figure 1

Due to these particularities, Argon, CO2 and NdYg lasers are used
for surgical incisions.
Through several scientific studies, one notes that variables in this
radiations wavelength, as well as in its power of emission, are responsible
for the success obtained in therapeutic pursuits.
With this in mind, CARCI developed a state-of-the-art laser emission
equipment, with wavelength and power variables for precise and adequate
treatment, according to the type of tissue involved, depth and pathological
phase.

MU_LASERMED_4098_ENG_Rev.05_092009

Lasermed

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Lasermed

Symbols
Equipment symbols

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Symbols on the pack

Equipment off

Caution fragile. Handle with care

Equipment on
Keep in a dry place

This equipment has physiological effects.

Consult instructions manual.

This side up. This symbol indicates the right

transport position

Applied part is type BF

Maximum piling. Indicates the maximum
number of boxes that can be piled. The
quantity is marked in the intermediary square.

Manufacturing date

Minimum and maximum temperature limits for

transport and storage.

Serial number

IPX0

Not protected from harmful water penetration

Manufacturer identification

Warning
1.
2.

This symbol indicates Hazard

Laser radiation

3.
Class II Equipment

This equipment should only be used by a qualified person

The operation in short distance (example: 1meter) from a
shortwave diathermy or a Microwave equipment can produce
instability on Lasermed operation.
Do not put the equipment in soft basis that can close the inferior
ventilation holes.

CE Mark and certifying body identification

European representative

MU_LASERMED_4098_ENG_Rev.05_092009

MU_LASERMED_4098_ENG_Rev.05_092009

Lasermed

4098

Lasermed

4098

Installation/ Grid Connection

The equipment must be positioned for use such that there is no obstruction
of the cabinets lower openings.
For perfect operation of your equipment, we suggest that the electrical
installations comply with the following standards:

Your equipment uses switched power supply and operates at any

voltage between 100 and 240V ~ 50 or 60Hz;

If the protective fuse burns, change it, as shown in the figure above,
for the value:

Brazil:

The fuses should be: 1.0A 250V (20AG)

NBR 5410/1990 Low-voltage electrical installations;

NBR13534/1995 Electrical installations in health establishments
Safety requisites.

Other countries:
IEC 60364-7-710/2002 Electrical installations medical locations;
Or another listed standard applied in the country of use.

Display language
LASERMED allows three display languages to be accessed:
Portuguese
English

The electric power supplys voltage must be within the range specified
in the Technical Features, otherwise, there can be reduced equipment
performance and safety risk.

Connect the power cable to the 3-pole connector located in the back
panel and connect it to the electric power socket;

Spanish
In case you wish to change the current language, follow the steps below:
1.

Connect the LASERMEDs power cable to the electric network.

2.

Switch on the device the equipment will test the display and
processor circuit, The display will give the following information:

SN.: 00001

3.

LASERMED
4098
Rev.: 4.3

Next, press and hold the key

Figure 02

MU_LASERMED_4098_ENG_Rev.05_092009

MU_LASERMED_4098_ENG_Rev.05_092009

Lasermed
4.
5.

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Lasermed

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After the equipment emits a beep, release the Keys .

Moves to the
next field

The display will show the accessible languages:

ENGLISH
PORTUGUESE
SPANISH

Decreases
6.

Increases

Select the desired language through the keys

Moves to the
former field

Set

7.

Press the key

8.

The equipment will exit the language selection mode, showing the
Main menu.

Functions of Controls
Laserrmed Panel

Infrared laser emission sensor.

Menu screens selection key

Key to enable the selected parameter.

Key to enable and disable the Lasermed probe.

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10

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11

Lasermed

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Lasermed

Laser Probes

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CONECTION LASER CABLE + LASER PROBE

Figure 05
Laser
aperture

Figure 03

LASERMED PROBE LABELS.

Lasermed Probe Infrared 830 nm Continuous (Blue Body)

LASER PROBE CABLE

Lasermed Probe Infrared 905 nm Pulsed (Blue Body)

Figure 04

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13

Lasermed

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Lasermed

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Toposcopic Probe

Lasermed Probe Infrared 650 nm Continuous (White Body)

1.
2.
3.

Toposcopic probe connector to the Lasermed

Active electrode
Neutral electrode (dispersive)

The laser probe label bears the following information:

Laser source class

Wavelength

Laser type (infrared or red)

Peak power/ Mean power

Serial number

Manufacturing date

Invisible laser radiation hazard

OBS.: Lasermed automatically detect which Laser probe is being used at the
moment.

Lasermed and toposcopic probe indication label

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Lasermed

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Modes of operation

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The display will give the following

information:

LASERMED 4098 has two modes of operation:

Lasermed

Therapy
Toposcopic
SN.: 00001

LASERMED
4098
Rev.: 4.3

In the Therapy mode, select the form of application:

1. Therapy Energy
Just set the value of the energy desired from 50 mJoules (0.05J)
to 10.000 mJoules (10J). The application time is calculated
automatically by the processor.

Right after, the equipment enters

the OPERATION MODE:

2. Therapy Nogier
Select the Nogier frequency desired or the frequencies
of 16Hz and 48Hz (calcium cycle), and the application time of
the frequency selected.
3. Therapy Free
Set the application time from 1 to 999 seconds;

Use the keys

to change to the Toposcope screen

THERAPY
905 nm

ENERGY
NOGIER
FREE
PROTOCOLS

MODE
LASER

Toposcopic Mode

MODE
LASER

TOPOSCOPY
905 nm

Sensitivity
Low
High
XXXXXXXXXXXXXXXXXXXX

Used to locate acupuncture points, or Trigger Points.

MODE
LASER

Device operation

Connect the power cable in the device to the power network;

Connect the laser cable to the laser pen and to the device (Figure 05
page 14);

Position the Master Control Key to

Press the ON / OFF switch at the back of the device (Figure 02 page
10);

MU_LASERMED_4098_ENG_Rev.05_092009

16

Or to use the Therapy mode.

MU_LASERMED_4098_ENG_Rev.05_092009

THERAPY
905 nm

ENERGY
NOGIER
FREE
PROTOCOLS

17

Lasermed

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1. Mode: ENERGY THERAPY

Press the key
to enable the mode: Therapy

Press the key

to enable the mode: Power

THERAPY
905 nm

probe's

ENERGY
NOGIER
FREE
PROTOCOLS

MODE
LASER
Set to Save
ENERGY
TIME

MODE
LASER
Set to Save
ENERGY
TIME
SENSOR
LASER

key.

To interrupt the application, press the

Press again to restart

key.

ENERGY
905 nm
J
S

00.00
000.0
Total
XXXXXXXXXX
OFF
00.00
000.0

ENERGY
905 nm

Press the

key to return to the main screen

2. Mode: NOGIER THERAPY

MODE
LASER

In the main screen, press the

ENERGY
NOGIER
FREE
PROTOCOLS

key to enable the therapy mode.

THERAPY
905 nm

J 00.10
S 000.5

00.00
000.0
Total
XXXXXXXXXX
OFF

The application time for the Energy desired is automatically adjusted by the
microcontroller.

MODE
LASER

Use the
keys to select the
Nogier mode.
Note : Just the probe 905nm is able
for Nogier function.

To enable the laser pen, press the

key of the panel.
The indication in the panel : LASER OFF ,
will change to
: LASER Stand By
and the pen's Green LED will remain on, showing that the probe is ready for
application.
Press the
Nogier mode.

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4098

To start the therapy, position the probe on the application site, and press the
MODE
LASER

SENSOR
LASER

Use the keys

for the Energy desired.

Lasermed

18

key

MU_LASERMED_4098_ENG_Rev.05_092009

THERAPY
905 nm

ENERGY
NOGIER
FREE
PROTOCOLS

MODE
NOGIER
LASER
905 nm
Set to Save
FREQUENCY
2.5 Hz
TIME
S 000.0 000.0
Total
SENSOR
XXXXXXXXXX
LASER
OFF

19

Lasermed

Use the
keys to
select the desired time.

MODE
LASER
Set to Save
FREQUENCY
TIME
SENSOR
LASER

4098

Lasermed

The indication in the panel : LASER OFF

will change to
: LASER Stand By
and the probe's Green LED will remain on, showing that the probe is ready
for application.

NOGIER
905 nm
2.5 Hz
S 001.0 000.0
Total
XXXXXXXXXX
OFF

To start the therapy, position the probe on the application site, and press the

probe's

key.

To interrupt the application, press the

Press again to restart.

Use the
keys to enable the
FREQUENCY Function

MODE
LASER
Set to Save
FREQUENCY
TIME
SENSOR
LASER

keys to
Use the
select the desired frequency.

MODE
LASER
Set to Save
FREQUENCY
TIME
SENSOR
LASER

NOGIER
905 nm
2.5 Hz
S 000.0 000.0
Total
XXXXXXXXXX
OFF

NOGIER
905 nm

MU_LASERMED_4098_ENG_Rev.05_092009

Press the

key.

key to return to the main screen

3. Mode: FREE THERAPY

In the main screen, press the

mode.

key to enable the therapy

48 Hz
S 010.0 000.0
Total
XXXXXXXXXX
OFF

Nogier Frequencies: 2.5 Hz; 5 Hz; 10 Hz; 20 Hz; 40 Hz; 73 Hz; 80 Hz; 146
Hz; 160 Hz; 262 Hz; 292 Hz; 584 Hz;
Calcium cycle activation frequencies: 16 Hz and 48 Hz.
These Frequencies are enabled for the 905 nm pen only.

To enable the laser probe, press the

4098

MODE
LASER
ENERGY
NOGIER
FREE
PROTOCOLS

MODE
LASER

keys to select
Use the
the Free mode.

THERAPY
905 nm

THERAPY
905 nm

ENERGY
NOGIER
FREE
PROTOCOLS

key of the panel.

20

MU_LASERMED_4098_ENG_Rev.05_092009

21

Lasermed
Press the
key to enable
the FREE mode of operation

Use the
the desired TIME.

keys to select

MODE
LASER
Set to Save
TIME
SENSOR
LASER

4098

Lasermed

FREE
905 nm

MODE
LASER

Use the
keys to select
PROTOCOLS.

S 010.0

000.0
Total
XXXXXXXXXX
OFF

Press the

To enable the laser pen, press the

key of the panel.
The indication in the panel : LASER OFF
will change to
: LASER Stand By
and the probe's Green LED will remain on, showing that the probe is ready
for application.

key

Use the
keys to
select the desired PROTOCOL.
4.1. RETURN Go back to the main
screen .
Press the

key to Return.

PROTOCOLS
RETURN
SAVE
USERS
FIX

key.
4.2.SAVE Record the protocol in the
memory.

To stop or reestart the aplication, press the key

of the probe.

To desability the use of the laser probe, press the key

Press the
record mode.

4. PROTOCOLS

The display will give the following screen :

In the main screen, press the

mode.

THERAPY
905 nm

ENERGY
NOGIER
FREE
PROTOCOLS

To start the therapy, position the probe on the application site, and press the

probe's

4098

key to enable the therapy

MODE
LASER

key to select the

THERAPY
905 nm

Use the
and
select the letter desired.

ENERGY
NOGIER
FREE
PROTOCOLS

Press the

keys to

key to write or the

key to erase.

MU_LASERMED_4098_ENG_Rev.05_092009

22

MU_LASERMED_4098_ENG_Rev.05_092009

PROTOCOLS
RETURN
SAVE
USERS
FIX

1 2 3 4 5
a b c d e
k l mn o
u v wx y
Stp to DEL

6
f
p
z

7
g
q

8
h
r
,

9 0
i j
s t
.

11--------------

23

Lasermed
PROTOCOLS
XXXXX
YYYYY
ZZZZZ

To save the protocols, press

4098

Lasermed

4098

STP TO DEL

the key
4.3. USERS The display will give the
following Protocols recorded
Press the
key to enable the
Selected mode Users.

Use the

keys to select the Protocol desired, and Press the

key to enable the selected Protocol.

For erase the Protocol, select the Protocol desired and press the
Key. The display will give the following screen :

For erase press the

key, or the

to keep.

PROTOCOLS
XXXXX
YYYYY
ZZZZZ

STP TO DEL

DELETE ?
SET = YES
MENU = NO

Use the

desired, and Press the

enable the selected Protocol.

To return to main screen, you must to select a Protocol and press

key

Press the

4.4. FIX The display will give the

following Lasermed Protocols.

MU_LASERMED_4098_ENG_Rev.05_092009

keys to select the Protocol

24

key to

key to enable the probe.

MU_LASERMED_4098_ENG_Rev.05_092009

PROTOCOLS
ATM
TORTICOLLIS
ARTHROSIS
ARTHRITIS
TENDONITIS
PERIARTHRITIS

BURSITE

25

Lasermed

4098

Lasermed

4098

Types of Application

5. TOPOSCOPY.

The application may be point or scan.

TOPOSCOPIC PEN OPERATION

In the main screen, use the
keys to select the screen:
TOPOSCOPY

PEN
MODE

THERAPY
905 nm

POINT:
Used when one wishes to deposit a determined energy at a point,
or to stimulate the acupuncture points, placing the laser probe perpendicular
to the skin.
The modes of operation used are: Continuous Energy and Nogier.

ENERGY
NOGIER
FREE
PROTOCOLS

Press the

key

PEN
MODE

TOPOSCOPY
905 nm

Sensitivity
Low

High

SCAN:
Used when one wishes to apply a determined energy on a
previously determined area. The laser radiation is applied by scanning the
entire area to be treated.
The mode of operation used is Continuous - Free

NOTE:
When asepsis of the location is required, do not touch the probe on the skin,
leaving it at a maximum distance of 1 cm.

Connect plug 1 (picture C, page 16) of the toposcopic probe to the

TOPOSCOPE PROBE connector of the device.
The patient must hold the negative electrode (3) of the toposcopic probe
firmly;
PEN
MODE

Use the keys

to increase the sensitivity
to the maximum.

TOPOSCOPY
905 nm

Master Control Key and Remote Interlock

Connector
Lasermed 4098 has two safety keys called Master Control Key and
Remote Interlock Connector to prevent use of the device by unqualified
personnel.

Sensitivity
Low
High
XXXXXXXXXXXXXXXXXXXX

With the active electrode (2) of the toposcopic probe touching the patients
skin, loop for the region of acupuncture points / trigger points.
A sound signal will be emitted.
Reduce the sensitivity gradually, and look for the acupuncture point in the
region selected; the sound signal emitted must be continuous and clear.

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27

Lasermed

4098

The Master Control Key locks the equipment, preventing enabling of the
laser probe.
When the key is in
unlocked.

, the device is locked, and in

Lasermed

4098

DOSIMETRY : Point application

the device is

When the key of the device is in

(locked), and the
key is
pressed, a sound signal (beep) will be emitted and the information LOCKED
will be displayed.

MODE
PROBE
ENERGY
TIME
LOCKED
Total
SENSOR

ENERGY
905 nm
mJ 01.50
S 001.5

00.00
000.0

XXXXXXXXXX

The Master Control Key is removable for user/owner safety.

The Remove Interlock Connector is an environmental protection device
(accessory). The key is connected to the Lasermed and the rooms entrance
door. If the door is opened, Lasermed suspends the operation, the display
will display the information LOCKED and the sound signal (BEEP) will be
emitted.

NOTE : The laser probes energy ,mentioned on table above, are for
point application.

Indications

GENERAL INDICATIONS

-

Traumatic lesions
Dermatology : ulcers / wounds
Esthetics : repairing surgeries
Ligament lesions
Cartilage lesions
Bed sores

MU_LASERMED_4098_ENG_Rev.05_092009

Inflammatory processes
Acupuncture
Muscular lesions
Tendinous lesions
Bone lesions

28

INDICATIONS REGARDING THE EFFECT (Point Application)

Analgesic Effect:
- muscular pain
- joint pain
Anti-Inflammatory Effect
Regenerative Effect
Circulatory Effect

:
:
:
:
:

2 to 4
4 to 8
1 to 3
3 to 6
1 to 3

MU_LASERMED_4098_ENG_Rev.05_092009

Joules/cm
2
Joules/cm
2
Joules/cm
2
Joules/cm
2
Joules/cm

29

Lasermed

4098

Lasermed

WAVELENGTH INDICATIONS
Pen 650 nm: skin lesions
Pen 830 nm: superficial lesions up to 2 cm depth
Pen 905 nm: deep lesions more than 2 cm depth
2

1 to 3 Joules/cm
2
4 to 6 Joules/cm
2
6 to 10 Joules/cm

acute lesions
sub-acute lesions
chronic lesions

DOSIMETRY SUGGESTIONS:

ATM :

Torticollis:

Arthrosis:

Arthritis:

Tendonitis:

Periarthritis:

Bursitis:

Sciatic pain:

Effort hernia:

Contusions:

Hematomas:

Epicondylitis:

MU_LASERMED_4098_ENG_Rev.05_092009

MODULATION FREQUENCY INDICATIONS:

Calcium cycle activation

16 Hz and 48 Hz

Immune system modulation

73 Hz, 146 Hz, 292 Hz

Chronic pain
2.5 Hz, 5 Hz, 20 Hz

Acute pain
80 Hz, 160 Hz, 262 Hz

Acupuncture Points
2.5 Hz, 5 Hz, 10 Hz, 20 Hz, 40Hz, 80 Hz

3 to 4 Joules/cm
Daily
2
4 to 5 Joules/cm
Daily
2
4 to 6 Joules/cm
Alternate
2
6 to 8 Joules/cm
Daily
2
4 to 8 Joules/cm
Daily
2
4 to 8 Joules/cm
Daily / alternate
2
4 to 7 Joules/cm
Daily
2
4 to 8 Joules/cm
Daily
2
4 to 6 Joules/cm
Daily
2
2 to 4 Joules/cm
Daily
2
4 to 6 Joules/cm
Alternate
2
4 to 6 Joules/cm
Daily

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Contraindications

ABSOLUTE CONTRAINDICATIONS

Retina
Neoplasias
Abdominal region of pregnant women
Metastases

RELATIVE CONTRAINDICATIONS

Near gonads and breast nodules

Hypo or hyperactive glands
Corticoid intake
Treatment with photosensitive drugs

Preventive and preservative maintenance

Avoid leaving the laser probe on Stand By for more than 5 minutes;

We recommend inspecting and calibrating the LASERMED 4098

once a year by CARCI;
30

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Lasermed

4098

Lasermed

Always make sure that the device is disconnected from the power
supply before cleaning. Avoid wetting the wire and connector electrical
contacts;

Use a cloth wet with water and soap to clean the cabinet of your
device and the probes, when necessary;

Check the equipment cables weekly, ensuring that they are not
defective;

On disconnecting the laser cable from the laser pen and device,
always remove it from the plug, thus preventing the cable from breaking;

Safety Warnings

Protect the eye region when applying on the face;

The use of safety goggles is recommended for both patient and

therapist;

Avoid looking directly at the laser source when on, since the laser
beam can damage the retina;

This equipment must be operated by qualified personnel only,

according to the legislation of the country of use;

This equipment is not protected against water penetration (IPX0). If

water enters the equipment by accident, do not connect it to the
power network. Send it to technical assistance to check for possible
damages;

Some materials, such as cotton, when saturated with oxygen, can be

ignited at the high temperatures produced by the LASER equipment.
Wait for the solvents from adhesives and inflammable solutions used
in cleaning and disinfecting to evaporate before using the LASER
equipment. Care must also be taken due to the possibility of ignition
in the presence of endogenous gases.

When the equipment is not in operation, it should be protected

against utilization by person non-qualified, removing the control
master key of its receptacle;

Do not dispose of this equipment or its accessories in the common

garbage at the end of its service life. This equipment contains
substances that are harmful to nature, if not treated correctly. If the
equipment or its accessories must be disposed of, submit the
material to CARCI, which will dispose of it properly.

Do not obstruct the laser emitter outlet

Do not let the probe suffer impacts or falls, since its interior contains
sensitive components that can be damaged;

Avoid contact of the laser emitter with sharp objects, which can
damage the emitters protector window;

This equipment has an estimated service life of 5 years. After this

period, we recommend subjecting the equipment to a full inspection by
CARCI in order to continue using it safety and efficiently;

Do not dispose of this equipment or its accessories in the common

garbage at the end of its service life. This equipment contains substances
that are harmful to nature, if not treated correctly. If the equipment or its
accessories must be disposed of, submit the material to CARCI, which
will dispose of it properly.

MU_LASERMED_4098_ENG_Rev.05_092009

32

4098

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33

Lasermed

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Corrective maintenance

Lasermed

4098

Technical features

Problem

Solution

Equipment does not on (1)

Check if the power cable is

connected to the power network
Check if the fuse is not
damaged
Contact technical assistance

Lasermed display informs:

Laser Fault

Check if the probe and the

cable are connected to the
device,
Check the probe cable
connections,
Change the probe cable.

Check the connection of the

After programming the laser, the
cable with the probe and device
Stand By LED (green) of the
Change the probe cable
probe does not come on
Contact technical assistance
The display informs:
LOCKED

Check if the MASTER

CONTROL KEY is in unlocked
position
Contact technical assistance

On changing to Test Mode, the

device does not display.

Check the connection of the

cable with the probe and device
Change the probe cable
Contact technical assistance

NOTE: Electrical diagrams, circuits and parts lists are not supplied to the end
consumers. If necessary, contact the CARCI Authorized Technical
Assistance.

MU_LASERMED_4098_ENG_Rev.05_092009

34

Origin
: CARCI Brazil
Model
: LASERMED 4098
Function and application : laser equipment for therapy
Power supply
: 100230 V~ automatic ( 10%) 50 / 60 Hz
Maximum Consumption
: 30 VA
ANVISA [National Health Surveillance Agency] Registration: AM10314290030
---------------------------------------------------------------------------------------------------- Classification according to EN 60601.1 and EN 60601.2.22 standards:
- Type of protection against electric shock:...........................................class II
- Level of protection against electric shock of the applied part:............type BF
- Level of protection against harmful water penetration:...........................IPX0
- Disinfection methods:....................................see preventive maintenance
- Level of safety of application in the presence of an anesthetic mixture
inflammable with air, oxygen or nitrous oxide:.........................not suitableMode of operation:...........................................................................continuous
----------------------------------------------------------------------------------------------------- Fuse
: 1.0 A 250 V 20 AG
Laser type
: Infrared and visible (red)
Laser pen automatic identification
Laser Emitters:
o GaAIAs MOCVD 650 nm 12 milli-Watts ( class 3b ) - Continuous
o GaAIAs MOCVD 830 nm 30 milli Watts ( class 3b ) - Continuous
o InGaAs MOCVD 905 nm 20 mili Watts average 60 Watts peak (
class 3b ) - Pulsed
- uncertainty of the values indicated: 20%
Automatic dosimetry time
Modulation frequency
: 16 Hz, 48 Hz and Nogier ( 10%)
Laser Probe 905 nm Operation Frequency : 2000 Hz ( 10%)
Laser Probe 905 nm Pulse Width
: 160 ns ( 10%)
Nominal ocular hazard distance (NOHD)
o Laser 905 nm = 1 meter
o Laser 830 nm = 10 meters
o Laser 650 nm = 100 meters

MU_LASERMED_4098_ENG_Rev.05_092009

35

Lasermed

4098

Beam divergence
:
0
0
o Laser 905 nm = 11 x 25
(II x )
o Laser 830 nm = beam collimated by lens (for this applier pen type,
the divergence can be neglected)
o Laser 650 nm = 0.8 mrad
Digital toposcopic probe
Dimensions
: 31 x 6 x 18 (WxHxL) (cm)
Weight
: 2.6 kg
Equipment operating conditions:
Room temperature
Relative humidity
Atmospheric pressure

Lasermed

Note: When replacing accessories, only use those indicated by CARCI. Use
of accessories not specified by CARCI can compromise equipment safety.
CARCI will not be held liable for such procedure.

Terminologies and Definitions:

For purposes of the standard NBR IEC 60601-1:1994 + amendment 1997,
the following conditions apply, used in the Manufacturer Declarations &
Orientations :
- Meaning given to the verbal forms should and may

: +15C to +40C
: 0% to 80%
: 700 hPa to 1060hPa

Environmental conditions for transport and storage:

o
Room temperature
: -10C to 50 C
Relative humidity
: 20% to 90%
Atmospheric pressure
: 500hPa to 1060hPa

Acessrios:
Cable for laser probe
3-pole power cable
Toposcopic probe 4090/40
User manual
Laser Probe pulsed 905 nm 60 Watts peak

Code 16567G
Code 14747G
Code 20429G
Code 10391G
Code 4097

Optional accessories:

Laser Probe 830 nm 20 milli-Watts

Laser Probe 650 nm 12 milli-Watts
Remote Interlock Connector
Safety goggles, with CE mark.

Code CARCI 21003G : wavelength : 600 to 700 nm, attenuation 90 %.

Code CARCI 17323G : wavelength : 800 to 950 nm, attenuation 70 %.

MU_LASERMED_4098_ENG_Rev.05_092009

4098

Code 4093
Code 4095

36

should means that compliance with the requirement or test in

question is mandatory in order to comply with the Standard.
would means that compliance with the requirement or test in
question is strongly recommended, but not mandatory in order to
comply with the Standard.
may means that compliance with the requirement or test in
question is only a particular way of obtaining compliance with the
Standard.

MANUFACTURER DECLARATION AND ORIENTATION - ELECTROMAGNETIC

EMISSIONS
LASERMED is intended for use in the electromagnetic environment described below. The
purchaser or operator of LASERMED must ensure that it is being used in such an
environment.
Electromagnetic environment Emission test
Compliance
orientation
LASERMED uses RF energy for its
internal operation only. Therefore,
its RF emission is very low and not
RF Emission
Group 1
likely to cause any interference in
CISPR 11
another
electronic
equipment
nearby.
RF Emission
LASERMED is intended for use in
Class B
CISPR 11
all establishments, including home
establishments and those connected
Emission of harmonics
Class A
directly to the public power network
IEC 61000-3-2
that supplies power to constructions
Voltage fluctuation / Flicker
with domestic purposes.
emission
Compliant
IEC 61000-3-3

MU_LASERMED_4098_ENG_Rev.05_092009

37

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4098

MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC

IMMUNITY
LASERMED is intended for use in the electromagnetic environment specified below. The
purchaser or operator of LASERMED must ensure that it is being used in such environment.
IEC 60601 Test
Compliance
Electromagnetic
Immunity test
level
level
environment - orientation
Electrostatic
6 kV contact
6 kV contact
The floor can be of wood,
discharge
8 kV air
8 kV air
concrete or ceramic. If the
IEC 61000-4-2
floor is covered with synthetic
material, the airs relative
humidity should be at least
30%.

Immunity test
Fast
Transients
Bursts
IEC 61000-4-4

Surge
IEC 61000-4-5

IEC 60601 Test

level

Compliance
level

2 kV supply
cable
1 kV signal
input and output
cable
1 kV differential
mode
2 kV ordinary
mode

2 kV supply
cable

<5% Ut
(>95% drop in Ut)
For 0.5 cycle
Voltage
drops,
short
interruptions and
voltage variations
in power supply.
IEC 61000-4-11

40% Ut
(60% drop in Ut)
For 5 cycles
70% Ut
(30% drop in Ut)
For 25 cycles
<5% Ut
(>95% drop in Ut)
For 5 s

Electromagnetic environment
- orientation

Lasermed

Magnetic fields of 3 A/m

3 A/m
The magnetic fields of the
the network
network frequencies must be
frequencies
levels characteristic of a typical
(50/60 Hz)
commercial
or
hospital
IEC 61000-4-8
environment.
Note: Ut is the AC network voltage before applying the test level.
MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC
IMMUNITY
LASERMED is intended for use in the electromagnetic environment specified below. The
purchaser or operator of LASERMED must ensure that it is being used in such environment.
Immunity
IEC 60601
Compliance
Electromagnetic environment test
Test level
level
orientation
Portable and mobile RF communication
equipment should not be used closer to
any LASERMED part, including cables,
more than the separation distance
recommended calculated by the equation,
applicable for the transmitter frequency.
Recommended separation distance

Not applicable
1 kV
differential
mode
2 kV ordinary
mode
<5% Ut
(>95% drop in
Ut)
For 0.5 cycle

The quality of the power

network must be that of a
typical hospital or commercial
environment.

40% Ut
(60% drop in
Ut)
For 5 cycles

4098

RF
Conducted
IEC 610004-6

3 Vrms
150 kHz to 80
MHz

RF
Irradiated
IEC 610004-3

3 V/m
80 MHz to 2.5
GHz

d = 1.17. P

80 MHz to 800 MHz

d = 2 .3 . P

800 MHz to 2.5 GHz

3V

3 V/m

Where P is the maximum output power of

the transmitter in watts (W), according to
the transmitter manufacturer, and d is the
recommended separation distance in
meters (m).
The field generated by fixed RF
transmitters, as determined by an
electromagnetic field in the locationa,
must be less than the level of compliance
in each frequency range. b

70% Ut
(30% drop in
Ut)
For 25 cycles

There can be interference around

equipment with the following symbol:

<5% Ut
(>95% drop in
Ut)
For 5 s

MU_LASERMED_4098_ENG_Rev.05_092009

38

MU_LASERMED_4098_ENG_Rev.05_092009

39

Lasermed

4098

NOTE 1: the greatest frequency in the range is applied in the range of 80 MHz and 800 MHz.
NOTE 2: this procedure may not apply in all cases. Electromagnetic propagation is affected
by absorption and reflection of structures, objects and people.

a.

b.

The intensity of fields generated by fixed transmitters, such as cell sites for telephones
(cell/wireless) and land mobile radios, radio hams, AM, FM and TV radio-diffusion
stations may not be theoretically prognosed accurately. To evaluate the electromagnetic
environment due to the fixed RF transmitters, an electromagnetic field study in the site
should be considered. If the field intensity measured at the site in which the
LASERMED is used exceeds the compliance level above, the LASERMED must be
observed to ascertain if it is working properly. If abnormal performance is noticed,
additional measures may be required, such as reorientation or relocation of the
LASERMED;
Above the frequency scale of 150 kHz to 80 MHz, the field intensity must be less than 3
V/m.

Lasermed

4098

Final Considerations
It has been Carcis policy to continuously improve the quality of its products.
Carci reserves the right to make modifications in the design and
specifications, and to also add to and improve its products, without the
obligation to install them in already manufactured products.
The text, illustrations and specifications contained in this manual are based
on information available during the printing.
All rights reserved.
This manual may not be reproduced in whole or in part without written
consent from Carci.

Manufacturer Data
Recommended separation distances between portable and mobile RF communication
equipment and the LASERMED
The LASERMED is intended for use in an electromagnetic environment in which the RF
disturbances are controlled. The purchaser or operator of the LASERMED can help prevent
electromagnetic interference by keeping a minimum distance between portable and mobile RF
communication equipment (transmitters) and the LASERMED, as recommended below,
according to the maximum output potential of the communication equipment.
Separation distance according to the transmitter frequency
Declared maximum
80 MHz to 800
800 MHz to 2.5
150 kHz to 80 MHz
output potential of the
MHz
GHz
transmitter (W)
d = 1.17 P

d = 1.17 P

d = 2.3 P

11.70 cm
11.70 cm
23.00 cm
0.01
37.00 cm
37.00 cm
72.70 cm
0.1
1.17 m
1.17 m
2.30 m
1
3.70 m
3.70 m
7.27 m
10
11.70 m
11.70 m
23.00 m
100
For transmitters with declared maximum output power not listed above, the recommended
separation distance (d in meters) can be determined using the equation applicable to the
transmitter frequency; where P is the maximum output power of the transmitter in watts (W),
according to its manufacturer.
NOTE 1: the 80 MHz and 800 MHz apply to the separation distance for the highest
frequency.
NOTE 2: this procedure may apply in all cases. Electromagnetic propagation is affected by
absorption and reflection of structures, objects and people.

MU_LASERMED_4098_ENG_Rev.05_092009

40

CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.

CGC [Corporate Taxpayers Roll]: 61.461.034/0001-78 .
I.E. [State Tax ID]: 110.182.450.113
Rua lvares Fagundes, 359

Americanpolis
So Paulo

SP
Brazil
Zip Code 04338-000
Tel. : (0XX11) 3346 2100
e-mail: [email protected]
website: www.carci.com.br
Carci Registration in the Ministry of Health: MS-10314290030
For Technical Assistance:
Departamento de Assistncia Tcnica [Technical Assistance Department]
Rua lvares Fagundes, 359 - So Paulo SP Brazil - Zip code 04338-000l
Tel. (0XX11) 5621 7024 / 5622 8205
Technical Responsible:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

WARRANTY CERTIFICATE IN ANNEX

MU_LASERMED_4098_ENG_Rev.05_092009

41

Lasermed

4098

EUROPEAN REPRESENTATIVE

EUROPEAN REPRESENTATIVE
OBELIS S.A.
34, Av. de Tervuren, bte 44
B-1040 Brussels, BELGIUM
Tel: (32) 2.732.59.54
Fax: (32) 2.732.60.03
E-mail: [email protected]

Bibliographical references
1- La Terapia Laser , Hoy
Josep Colls Edita Centro de Documentacion Laser Barcelona 3
edicion - 1986
2- Physical Agents in Rehabilitation From Research to Practice
Michelle H. Cameron - W.B. Saujnders Company Philadelphia 1
Edition - 1999
3- Therapeutic Lasers - Theory and Practice
G. David Baxter Churchill Livingstone - 1994
4- Tratamientos con Laser Metodo Diagnostrat
Carlos Lasvi Minaguano Ediciones Madrid - 1986
5- Laser y Terapeutica em Medicina
6- J.L. Cisneiros M.A Trelles Centro Documentation Laser Barcelona
1 Edicion - 1987
7- Low Reactive Level Laserf Therapy Practical Application
T. Oshiro John Wiley & Sons Ltd 1 Edition 1991

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