3B LASER PEN 200 User manual

3B LASER PEN 200
Operating Instructions
Last revised 2017-11-08

Function Keys and Display Elements ...................................................................................................................................................... 5
Display and LED Displays ............................................................................................................................................................................. 6
peration .......................................................................................................................................................................................................... 7
Changing the Laser Parameters ................................................................................................................................................................ 8
Using the Laser ............................................................................................................................................................................................. 10
Searching for acupuncture points ......................................................................................................................................................... 12
Application .................................................................................................................................................................................................... 13
Use ..................................................................................................................................................................................................................... 14
Adjunctive Use .............................................................................................................................................................................................. 14
Contraindications ......................................................................................................................................................................................... 14
Maintenance and Care .............................................................................................................................................................................. 15
Installing and Charging the Batteries .................................................................................................................................................. 15
Safety Information ....................................................................................................................................................................................... 16
Manufacturer’s Labels and Warning Signs ......................................................................................................................................... 17
Accessories ..................................................................................................................................................................................................... 18
Technical Data for 3B LASER PEN 200 ...................................................................................................................................... 19
Appendix 1: Therapy Frequencies / Therapy programs ................................................................................................................ 21
Scope of Delivery
The following units are included in the delivery:
• 3B LASER PEN 200
• Charging station incl. power supply unit
• Key pin
• Rechargeable batteries (2)
• Laser protection glasses for therapist
• Laser protection glasses for patient – SoftCap
• Case
• perating instructions
2 Last revised 2017-11-08

Dear User,
We are glad that you have selected an ultra-modern, quality medical product in the 3B LASER PEN, and would like
to thank you for placing your trust in us.
In order to achieve the success you are looking for and to ensure that you have many years of use from your 3B
LASER PEN, we would ask you to read the following usage information carefully.
If you have any questions, please feel free to contact us via e-mail: [e-mail].
Specific therapy advice can be obtained from specialist publications or by attending user courses and workshops
This manual has been written for the operators of the 3B LASER PEN . It contains general instructions for operation,
precautionary instructions, and maintenance recommendations . In order to obtain maximum life and efficiency from
your 3B LASER PEN, and to assist in the proper operation of the unit, read and understand this manual thoroughly.
Precautionary instructions
The precautionary instructions found throughout this manual are indicated by specific symbols. Understand this
symbols and their definitions before operating this equipment . The definition of these symbols are as follows:
Text with “CAUTI N” indicator will explain possible safety infractions
that could have the potential to cause minor to moderate injury or
damage to equipment.
Text with a “WARNING” indicator will explain possible safety infractions
that will potentially cause serious injury and equipment damage.
Text with a “DANGER” indicator will explain possible safety infractions
that are imminently hazardous situations that would results in death
or serious injury.
• Read, understand, and practice the precautionary and operating instructions. Know the limitations and hazards
associated with using any laser light device . bserve the precautionary and operational decals placed on the unit.
• Do not operate this unit in an environment where other devices are being used that intentionally radiate elec-
tromagnetic energy in an unshielded manner . Portable and mobile RF communications equipment can affect
Medical Electrical Equipment.
• Handle the unit with care and in accordance with the instructions outlined in the manual . Inappropriate handling
of the unit may adversely affect its characteristics.
• This unit should be operated in temperatures between 50 to 86 °F (10 to 30 °C), and transported and stored in
temperature between 32 to 122°F (0 to 50 °C), with relative humidity ranging from 30 % to 75 %.
• Do not disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, elec-
trical shock, fire, or personal injury.
• Failure to use and maintain the 3B LASER PEN and its accessories in accordance with the instructions outlined in
this manual will invalidate your warranty.
• Do not open the housing . This may cause unit damage, malfunction, electrical shock, fire, or personal injury. If a
malfunction occurs, discontinue use immediately and consult the dealer for repair service.
• Do not permit any foreign materials or liquids to enter the unit . Take care to prevent any foreign materials inclu-
ding, but not limited to, inflammables, water, and metallic objects from entering the unit . These may cause unit
damage, malfunction, electrical shock, fire, or personal injury.
• If you have difficulty operating the unit after carefully reviewing this user manual, contact your dealer for assistance.
• U.S . federal law restricts this device to sale by, or on the order of, a physician or licensed practitioner.
• This unit generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation . Harmful interference to other devices can be determi-
ned by turning this unit on and off.
• You must only connect original 3B parts due to the scope of delivery. ther parts or materials can degrade mi-
nimum safety.
Last revised 2017-11-08 3
= CAUTI N
= WARNING
= DANGER
C
AU
T
I
O
N
WARNING
DANGER

WARNING
• Be sure to read all instructions for operation before treating a patient. bserve the regulations for handling the
3B LASER PEN.
• Do not drop the unit, accessories on hard surfaces . Do not submerge the unit, accessories in water. All of these
conditions will damage the unit . Damage resulting from these conditions is not covered under the warranty.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in
hazardous exposure to laser light energy.
• This device should be kept out of the reach of children.
• This device should be used only under the continued supervision of a licensed practitioner.
• Dispose of all products in accordance with local and national regulations.
• This equipment is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause
malfunction of internal components of the system and therefore create a risk of injury to the patient.
• Use of controls or adjustments or perfomance of procedures other than those specified herein may result in ha-
zardous conditions causing damage to the unit and applicator.
• Care must be taken when operating this unit adjacent to or stacked with other equipment . Potential electromag-
netic or other interference could occur to this or other equipment . Try to minimize this interference by not using
other equipment (i.e . cell phones, etc.) in conjunction with it.
• Use only accessories that are specially designed for this unit . Do not use accessories manufactured by other
companies.
• Use of other accessories other than those specified may result in increased emissions and decreased immunity.
• If laser is not in use, shut of the unit with key „Power“.
• Laser equipment not in use should be protected against unqualified use.
• Some patients are more sensitive to laser output (i.e., patients taking medications that increase sensitivity to light)
and may experience a reaction similar to a heat rash.
DANGER
• Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to eva-
porate before the unit is used.
• Avoid direct eye exposure . Laser protective eyewear should be worn by the operator and patient to block infrared
light energy from the eyes during treatment.
• Do not point the laser light beam directly into human or animal eyes.
• bserve the safety information.
4 Last revised 2017-11-08

Function Keys and Display Elements
11
7
Last revised 2017-11-08
1
2
6
1
3
2
4
5
8/9/10
13
5
1 LASER The laser is activated/deactivated with this key.
2 + / - The values selected with the SET key can be changed with these keys.
3 SET The values can be selected and stored with this key.
4 P WER The 3B LASER PEN is switched on and off with this key.
5 Display
The selected laser power level, operation mode, point search mode, therapy time, and
dose rate as well as information about the battery charge are shown on the display screen.
6 LED
This LED above the LASER key indicates whether the laser has been activated. An error in
the laser diode operation is indicated by a red light . When this happens, please contact
our technical service.
7 Battery compartment Battery compartment Is at the bottom of the housing.
8 Red connector Red connector connector for the key pin
9 Charging contacts Charging contacts for the charging station
10 Black connector Connector for storing the key pin
11 Contact surface For the point search
12 waveguide Laser beam outlet
13
Charging station with
power supply unit
For charging the batteries

Display and LED Displays
This screen appears during the booting process after the laser unit has been tur-
ned on. The first line shows the specific model, and the second line the software
status of the unit.
This screen appears after the laser unit has been turned on once the booting
process is finished . The second line shows the wavelength and the maximum
CW output of the specific model . The battery charge status is shown on every
screen . The loudspeaker icon indicates whether the sound is activated . If the
sound is deactivated, the loudspeaker icon is crossed out.
Base setting . The current therapy parameters (laser power, point search
program, therapy program, energy dose rate) and the battery charge status are
displayed.
A value that appears highlighted can be changed with the + and - keys . n this
screen the laser power can be altered . Pressing the SET key saves the selected
value . The parameters output, point search mode, therapy programs, energy
dose rate, and/or therapy time can be altered.
Setting the point search mode and starting the laser unit manually or
automatically . M = manual point searching, A = automatic point searching,
0 = point searching not activated
Setting the therapy program.
Setting the energy dose rate. Max. = 240 J
Setting the therapy time. Max. = 10 min.
In point search mode M, the conductance of the skin is indicated by a bar chart
and shown as a digital value (0–99).
In point search mode A, the stored skin conductance value is shown as a
hatched bar and as a digital value in the second line.
This screen appears when the laser is activated . Laser power level, point search
program, as well as the remaining therapy time and the discharged energy dose
rate in J are shown.
Last revised 2017-11-08
2
0
0
m
W
4:43 - .
3.4
M
6
3
B
L
A
S
ER
P
E
N
V.3.2US
3B LASER PEN
808nm 200mW
2
0
0
m
W
A
200m
W
M
200m
W
M
200mW
M
200m
W
M
200m
W
M
M
A
6
0
.
0
J
CW
60.0J
CW
60.0J
CW
60.0J
CW
60.0J
CW
5:00
CW
63 LW
00 LW

This screen appears when the batteries are empty and must be charged . In this
condition it is not possible to activate the laser pen.
The charging process is indicated with this screen.
When this appears, insert key pin into red connector.
Warning: laser power error . This message appears when the laser power level
may be outside the tolerance range . In most cases, however, this is due to
reflections on reflecting surfaces (wet and/or white surfaces) . Please notify
our Service Department if you see this error message repeatedly.
Error in the laser diode operation (laser power too low).
If you see this message repeatedly, the laser diode is most likely defective . In this
case please notify our Service Department.
LED display of laser power level: The green LED indicates that the laser is actived.
LED display says “Error”: The red LED indicates that an error has occured . In this
case always check the message on the display.
Laser pen can only be operated when the key pin has been inserted into the
red connector . To insert the key pin in the black connector will lock the unit.
Operation
You may only use the 3B LASER PEN with inserted wave guide. Never use the 3B LASER PEN without wave guide.
Insert the red key pin into the red connector on the left (8) and turn on by pressing the P WER key (4). The display
now shows the following message:
3B LASER PEN
XXXnm XXX mW
The output data of the specific laser system (wavelength and max . output) are indicated in the second line.
Last revised 2017-11-08 7
W
A
R
NI
N
G
3B LASER PEN
808nm 200mW
WARNING
WARNING
High Laser Power
WARNING
Low Laser Power

You can turn around the display (right-handed/left-handed users) with the “+” key (2) . The sound (which is
issued every 20 s during laser discharge) can be turned on and off with the “-” key (2) . When the loudspeaker
icon is crossed out, the sound is turned off.
By pressing the “SET” key you can then have the current parameters (initial setting) of the unit shown as follows:
60.0J
CW
The display always shows the values for laser power, point search mode, therapy program, and energy dose
rate that were selected last (stored).
When the unit is operated for the first time, the maximum output (200 mW), the operation mode CW, point
search mode FF (0) and the energy dose rate 60 J (Therapy time 5 min.) are always preset.
The parameters can be modified as explained in the chapter “Changing the Laser Parameters”.
The laser discharge is started as explained in the chapter “Using the Laser”.
Changing the Laser Parameters
When the SET key (3) is pressed, the output value flashes as in the illustration below and can be changed with
the “+” and “-” keys (2) . The settings can be 100 / 200 mW.
60.0J
CW
By pressing the SET key (3) again, the selected value is confirmed and stored . The display changes to the
following screen . The point search mode can now be altered with the “+” and “-” keys (2).
60.0J
CW
The setting options for the point search mode are “0” (point search off), “M” (manual point search) and “A”
(automatic point search) . (See the chapter “Point Search”. By pressing the SET key (3), the selected value is
confirmed and stored.
The information on the screen changes into the following display.
60.0J
CW
The therapy program can be changed with the “+” and “-” (2) keys and saved with the SET key.
The setting options are:
CW – Multifrequency – Alpha frequency – Nogier frequencies A–G – Bahr frequencies 1–7 – Reininger
frequencies 1-12, – Nogier frequencies pot
. A’–G’ – freely programmable frequencies between 1 and 9999 Hz
For therapy programs and frequencies, see Appendix 1.
2
0
0
m
W
A
20
0
m
W
M
2
00
m
W
M
2
00
m
W
M
8 Last revised 2017-11-08

A single frequency can be selected as follows:
When the value on the display flashes, go to the respective frequency program by pressing the “+” or “-”key.
Then press the SET key for 2–3 sec . This gets you into the setting mode for the specific frequency . Use the “+/-”
key to select the desired frequency and confirm it with the SET key . When you press SET again, the selected
frequency is shown on the display (now the value frequency is stored and now more flashing).
Setting a freely programmable frequency:
Twenty memory locations FP1 to FP20 are available for freely programmable frequencies . When the value
flashes, press the “+” or “-” key to enter the frequency program FP . Keep the SET key pressed for 2–3 sec . to
get to the “Pro-grammable” screen on the display.
Programmable
FP1: xxx Hz
Keep the SET key pressed for 2–3 sec . to enter the frequency setting mode.
Frequency x
xxxx.xx Hz
You can set the desired frequency (1 – 9999,99 Hz) with the “+/-” and SET keys . First the thousands digit, then
the hundreds digit, etc . nce the desired frequency has been set, confirm with the SET key (keep pressed for
2–3 sec.) . The frequency is now transfered to the treatment screen on the display (at first as a flashing value).
The frequency is stored with the SET key and displayed on the screen.
A value that has been set remains in the memory until it is overwritten by another frequency.
After the treatment mode has been set, the display changes to:
60.0J
CW
The energy dose rate can be changed with the “+/-” keys. The SET key confirms the selected value . Depending
on the selected laser power the LASER PEN calculates automatically the therapy time required.
5:00
CW
Please note: Changing the therapy time with the “+/-” keys also changes the dose required for this therapy time
depending on the selected output.
Last revised 2 017-11-08 9
2
00
m
W
M
20
0
m
W
M

Possible settings for the therapy time are:
10 sec.–1 min. in 20-sec . increments
1 min.–20 min. in 1-min . increments
Possible settings for the dose are depending on the specific model and are :
3B LASER 200 / 1 J–240 J max.
nce all laser parameters have been set, this is shown in the display . The different values are now no longer flashing
and you can start with the laser treatment – see the chapter “Using the Laser.”
Please note:
The maximum energy dose rate that can be selected is determined by the maximum therapy time and the maximum
laser power of the laser pen.
Example: Maximum therapy time for the 3B LASER PEN 200 is 20 minutes and maximum laser power is 200 mW . The
maximum energy dose rate that can be set is therefore 200 mW * 20 minutes * 60 s = 240 J . The minimum dose that
can be selected is 1 J.
Please note: Due to the correlation between energy and therapy time, changing one of the two
parameters will also impact the other parameter. The respective other value will be automatically
adjusted accordingly.
The selected value for the therapy time is confirmed and stored by pressing the SET key (3) again . You can now start
using the laser (see the chapter “Using the Laser”).
Please note: The settings for the parameters are retained when the unit is turned off and on again.
Using the Laser
The laser application can now be activated, if the base setting (display of the parameters) is shown on the screen.
Please note: It is not possible to activate the laser, if a parameter is still flashing.
200mW 60.0J
A CW
Pressing the LASER key (1) activates the laser after a 2-sec . warm-up period. The LED (6) lights up green and the
display changes to the following screen:
200mW
4:43 - 3.4J
The display (5) now shows the remaining therapy time and the emitted energy dose rate in Joule as well as the
selected point search mode. The selected therapy time now counts backwards and the energy dose rate changes in
line with the selected laser power and the elapsed therapy time according to the formula “Energy dose rate (Joule) =
Laser power (mW) x Therapy time (sec.)”.
If the loudspeaker has been turned on, a signal will sound every 20 sec.
10
M
Last
revised
20
17
-
11
-
08

Treatment ends automatically after the selected therapy time has elapsed or when the selected energy dose has
been achieved. The end of the therapy is indicated by short triple sound signal.
Treatment can be terminated manually at any time by pressing the LASER key (1).
nce the therapy has ended, the screen changes back to the “Base setting” display.
Note: When no laser application is taking place, the unit turns “ FF” automatically, if it is not operated
for a period of >= 10 minutes (AUT FF).
1. The 3B LASER PEN must only be operated with inserted laser tip.
2. Risk of burns:
When the laser out put is >300 mW, especially in CW mode, the skin is heated. Please alert the patient to this fact.
Terminate the therapy session immediately when the patient finds the laser therapy too hot.
No direct irradiation of tattoos, moles, highly pigmented skin or from a distance to the treatment area less than 2 cm.
Max. dosage in treatments per patient: 60 Joule.
Please double-check on the monitor that the correct dosage has been set before starting treatment. The therapy time
is calculated automatically on the basis of the selected laser power and programme.
Maximum treatment time per patient is 20 min.
3. Risk of infection:
When treating injured skin and wounds, avoid direct contact with the skin to prevent contamination with germs.
In the presence of wounds and injuries, keep a distance of approx. 1 cm to the skin.
4. Please replace the tip after each treatment. A second tip has been provided.
Disinfect the laser tip after each treatment.
The tip may be disinfected in an autoclave or via spray-and-wipe disinfection with a 70% alcohol.
The 3B LASER PEN works with a maximum laser output of 200 mW. At maximum power (200 mW in CW mode) and
a fully charged battery, the battery time is approx. 1 h.
If the battery time becomes significantly shorter, replace the batteries with new ones.
As a general rule, the unit should be placed in the charger station after every application. But note that the laser pen
must be charged whenever the battery level indicator is <50%.
Charge the unit as long as possible, preferably until the charge symbol “disappears” (4 h).
Always keep a fully charged replacement battery at hand. Please note the user manual for the charger that has been
supplied.
Use only batteries of the same kind (AA – NiMH 1.2 V – min. 2,450 mAh). How to replace the batteries is explained
on p. 15 of the User Manual.
Last revised 2 017-11-08 11

Searching for acupuncture points
Acupuncture points exhibit a different electronic response compared to the immediately adjacent areas of skin which
appear visibly identical. These points can be detected as zones with an increased skin conductivity (equivalent to a
reduced electric resistance of skin).
This fact is the basis when working with a point searching unit. To activate the point searching device you need to
change into the modus M. From the starting position press the key SET twice. Now you can change the modus with
keys + or -. The following modus are possible:
• 0 = point searching off, M = manual point searching, A = automatic point searching
Modus M (manual point searching)
By touching one of the metallic contact surfaces and simultaneously
tou-ching the skin of the patient the point searching is active.
(See picture) The skin conductance is displayed both as a bar image and
as a digital value (0-99). A sound signal shows if the value of the skin’s
conductance is getting higher or lower.
Gently press the 3B LASER PEN perpendicularly onto the skin in the vicinity
of the expected acupuncture point . You can search for acupuncture points
by moving the 3B LASER PEN over the skin.
Skin zones exist where the conductivity value is below the measuring range
(display indicates a value of 0). In this case you must press the
3B LASER PEN more firmly onto the skin or slightly moisten the area . In the
modus M (manual point searching) you can activate the 3B LASER PEN by
pressing the key LASER key at the highest measured value.
Modus A (automatic point searching)
If you stay in modus M (manual point searching) and you briefly press the SET key you can store the actual skin
conductance . The stored value is shown on the display as a digital value and as a hatched bar. The point searching
modus in the display changes to A. The automatic laser function has now been activated.
While point searching there is always a continuous comparison between the actual skin conductivity and the stored
value . If you find a point with a higher conductivity as the stored value then this is seen in the bar-display . If the
3B LASER PEN is not moved, and the actual measured value is stable for 2 seconds and greater than the stored
value, the 3B LASER PEN automatically switches on . Now the display indicates the therapy time and the
treatment dose.
Measurement
For example, if you store the skin’s conductivity value at point A1 and then move the 3B LASER PEN in the
direction of A2, the displayed conductivity values will be greater than 60 in this example.
If you carry out the measurement at A2, conductivity values will only be displayed where the compared value is
greater than 80 . Any points below 80 will not be displayed, etc.
12 Last revised 2017-11-08

measurement (A3)
value e . g . 90
measurement (A2)
value e. g . 80
measurement (A1)
value e. g . 60
This method allows you to locate the acupuncture point relatively accurately.
To search for another point, first remove the 3B LASER PEN from the skin . The laser switches to the automatic
status again, the measured value remains stored.
To delete the stored value you have to press the SET key. After doing that you are back in the basic setting and the
point search modus is FF.
The complete procedure as described must be repeated each time you search for a new point.
Please note:
Switching-on the laser does not necessarily mean that you have found an acupuncture point . It only means that the
current conductivity value is higher than the stored value . It may well be the case that you have to carry out several
measurements before you find the point.
Working with the 3B LASER PEN does not replace knowledge of the positions of acupuncture points. Extremely
moist, dry or hairy skin, or also an extremely high atmospheric humidity in the room, may lead to faulty results.
Acupuncture points can possibly lie very deep under the skin and are extremely difficult to find. The same applies
to points which are not active . It is extremely difficult, and sometimes even impossible, to find such points using
a point searcher. A measurement is very accurate if the acupuncture points are located relatively far apart. It is un-
derstandable that point searchers will have difficulties if the acupuncture points are situated very closely together.
Application
The following must be observed if you wish to achieve optimum
success with the therapy.
• To keep reflection losses as low as possible, skin must be
grease-free, and the 3B LASER PEN must be held
perpendicular to the skin.
• A general rule that applies to all treatments is the principle
of tapering dosage . Initial treatments should last no longer
than 5 minutes.
• Maximum treatment time per patient is 20 min . After this time the unit turns off automatically.
• The distance between the applicator and the skin should be no more than a few mm, or direct contact.
13 Last revised 2017-11-08

• Move the 3B LASER PEN over the skin slowly and uniformly, and only activate it when it is in treatment position.
• nly apply creams or lotions after the laser treatment has been finished . Clean the laser beam outlet using 70 %
ethanol following each contact with skin and for each new patient.
Use
The 3B LASER PEN is intended to provide topical heating for the purpose of elevating tissue temperature
for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the
temporary increase in local blood circulation and/or promoting relaxation of muscle.
Adjunctive Use
The 3B LASER PEN may be used adjunctively for the following:
• symptomatic relief of minor pain
• minor muscle and joint pain
• minor muscle
• spasms
• relief of associated minor stiffness and pain associated with arthritis - promoting relaxation of muscles
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contraindications and Precautions
The following contraindications and precautions are referred to in the laser literature:
Absolute:
• Irradiation of eyes
• Photosensitivity
• No direct irradiation of cancerous tissue
• pen fontanels and epiphyseal cartilage in children
• Thyroid gland hyperactivity
Relative:
• Pacemaker patients (thorax)
• Epilepsy(head)
• Pregnancy (stomach and back regions)
• Endocrine organs (Thyroid gland, testicles, ovaries)
Therapy hindrances:
• deep X-ray treatment
• permanent medication
• chemotherapy
Last revised 2017-11-08 14

Maintenance and Care
To ensure safe and hygienic operation, please observe the following:
• The laser beam outlet must be cleaned with a cotton swab using 70 % ethanol (medical alcohol) every
time it has come in contact with skin or for each new patient.
• Do not expose the unit to direct sunlight.
• The housing may be cleaned with a mild detergent and a damp cloth . The 3B LASER PEN must be dis-
connected from the charging station for cleaning . Disconnect the power cord before cleaning.
• Unauthorized repairs or modifications of the 3B LASER PEN may put users or patients in jeopardy.
Therefore repairs may only be performed by the manufacturer or by persons who have been authorised
by him. Unauthorized opening may result in the uncontrolled discharge of laser radiation and will void
the warranty. Please contact the technical service if repair is necessary.
• perate the 3B LASER PEN only in closed rooms at room temperature . The laser warning sign which has
been supplied must be attached to the door.
• Please protect the unit against moisture.
Installing and Charging the Batteries
The laser pen 3B LASER PEN must be charged prior to first use. To do this open the battery compartment cover
on the back of the 3B LASER PEN carefully with a pointed object and insert the two rechargeable batteries
supplied . Make sure to match the + and – symbols in the compartment . Replace the battery compartment cover
firmly.
Use only the rechargeable batteries supplied or batteries that conform to the technical specifications indicated
(see the chapter “Technical Data”). Never use normal batteries . Using the wrong rechargeable batteries or normal
batteries may damage the unit.
Connect the charging station supplied to the power source (100 V–230 VAC) and insert the 3B LASER PEN
vertically into the charging station . The battery charge status is always shown in the display (5).
When the charging process is complete (the batteries are fully charged) remove the 3B LASER PEN from the
charging station.
The display now looks like this:
Charge status Battery empty Battery is Battery is
battery ½ full being charged fully charged
15 Last revised 2017-11-08

Important: The 3B LASER PEN may not be stored with empty rechargeable batteries. We recommend
removing the rechargeable batteries if you are not intending to operate the unit for a period of >1 month . Rechar-
geable batteries that have been removed must be charged at least every three months . The battery charge control
takes the memory effect into account, so you can charge the device after each treatment without having to worry.
Safety Information
Please observe the instructions in the operating manual strictly and heed the warnings (see warning signs in the
chapter “Manufacturer’s Labels and Warning Signs”) . Using the operating elements, settings and procedures
other than described in the operating instructions may result in hazardous laser radiation.
The 3B LASER PEN must be protected against unintentional operation by using the key pin.
To this end, insert the key pin into the black connector (10) after you are finished using the unit.
The 3B LASER PEN may only be operated by specialized medical staff who have been trained in handling the unit
(see appendix: “List of Medical Devices”). Treatment must be supervised at all times.
Portable and mobile HF communication devices can disrupt the proper functioning of the unit . This device is subject
to special precautions regarding EMC and therefore may only be installed and operated in accordance with the
instructions provided in the accompanying document entitled “Notes on Electromagnetic Compatibility”.
Do not look into the laser beam outlet and do not point into the eyes of other persons even if the eyes are closed.
During laser applications near the eyes, the eyes require special protection.
The safety distance for the 3B LASER PEN 200 is 100 cm (39.37 inch).
If used incorrectly, lasers can damage the eyes, especially if the distance between the eye and the laser beam outlet
is shorter than the safety distance.
Please make sure that no mirrors or other reflecting surfaces are located within the safety distance from the
3B LASER PEN (reflection of laser light).
User and patient must always wear laser protection glasses. Laser protection glasses are part of the delivery.
The laser system must only be switched on when it is in the treatment position (in direct contact with or a few mm
distance from the treatment area). When the treatment position is changed, the laser must be turned off and only
be turned on again when it is in the new treatment position . After the treatment the 3B LASER PEN must be
switched off.
If the 3B LASER PEN or the charging station shows any signs of external damage, the device may no longer be
operated and must be returned to the manufacturer.
Magnetic and electric fields as well as ionizing radiation may influence the functioning of the unit . For this reason
you should not operate the laser system near devices which generate large electromagnetic fields or ionizing ra-
diation, such as X-ray machines, diathermy equipment, and wireless telephones. Do not operate the unit in rooms
which are subject to the risk of explosion.
The 3B LASER PEN and the rechargeable batteries are subject to the WEEE Directive (waste of
electrical and electronic equipment) 2002/96/EC and must not be disposed of as normal household
waste . This also applies to the rechargeable batteries that are part of the unit.
Last revised 2 017-11-08 16

The manufacturer is only responsible for safety and reliability if the laser device is used in accordance
operating instructions.
perate the 3B LASER PEN only in closed rooms at room temperature . The laser warning sign which has been
supplied must be attached to the door.
Manufacturer’s Labels and Warning Signs
3B LASER PEN 200
3B LASER PEN charging station
Label for charging station
SN: 102449-00004
CAUTION • WARNING
Federal law restricts this device to sale by or on the order of a physician.
Use carefully . May cause serious burns . Do not use over sensitive skin
areas or in presence of poor circulation . The unattended use of 3B Laser
Pen by children or incapacitated persons may be dangerous.
Last revised 2017-11-08
wi
t
h
t
h
e
Po
wer
S
u
pp
ly
3B LASER PEN XXX mW
50/
1
1
C
A
UT
I
O
N
17
WARNIN
G
INVISIBLE LA SE RRADIATI N
AV ID EXP SURE T THE BEAM
CLASS 3B LASER PR DUCT
Laser warning sign, hazard symbol according to IEC 60825-1
and warning of laser radiation/power
Warning label of the radiation / laser power emitted according
to IEC 60825-1
LA-X 200 = P0 max . 200 mW / ^ = 808 nm
AVOID EXPOSURE
INVISIBLE LASERRADIAT N IS
EMITTED FR M THIS APERTURE
Label at the laser beam outlet
Manufacturer’s label
Models
3B Laser 200
CE
0197

Labels
Accessories
• Protective Glasses – Therapist
• SoftCap Protective Glasses – Patient
• Rechargeable AA-size NiMH batteries – 2,600 mAh
Last revised 2 017-11-08 18
bserve the operating instructions
bserve the disposal regulations
livetec GmbH
79539 Lörrach
Germany
Name of manufacturer
2011
Production date
CE symbol
0197
Notified body

Technical Data for 3B LASER PEN 200
Protection class II according to IEC 60601-1
Application unit BF according to IEC 60601-1
Class IIa according to RL 93/42 EEC
Laser class 3B according to IEC 60825-1
IEC 60825-1 safety distance 100 cm
Without moisture protection (IPX0)
IEC60601-1 Medical electrical devices
IEC60601-1 Medical devices, EMC standard
IEC60601-2-22 (Ed . 3) Medical devices, laser application standard IEC60825-1:
IEC60825-1 Safety of laser devices
3B LASER PEN 200: 200 mW / 808 nm
Semiconductor laser
See Appendix 1
20 minutes max.
808 nm: x-direction 8-11°, y-direction 39-48°
“ N/ FF” key for switching the laser output on or off
Green LED “P WER”: laser output is activated
Red LED “ERR R”: error message concerning laser power monitoring
LCD: 128 x 32 points to display the therapy parameters and error
messages
Via integrated rechargeable batteries (NiMH)
NiMH(2 cells) / 1.2 V, AA size, 2,600 mAh capacity
Via multi-voltage power supply unit
Primary: 100–240 VAC / 50–60 Hz / 400 mA
Secondary: 12V / 1.25 A / 15 W / short-circuit-proof
Manufacturer: Friwo, type FW 7555M/12
2 A, power supply unit also short-circuit-proof
perating temperature: 10° C–30° C
Applicator: W x H x D = 34 x 36 x 225 mm Charging station: W x H x D = 107 x
35 x 106 mm
Last revised 2017-11-08
Dimensio
ns
1
9
Classific
ation
and
standards
Classification
Standards
Laser power
Effective laser output, wavelength
Type of laser
Therapy programmes
Therapy time
Beam divergence
Operation
perating elements
Display elements
Power supply, operating unit
Power supply
Rechargeable batteries
Power supply (during the charging process)
Safety fuse
Mechanics and environment
Permissible temperature range and relative
h idit
General
Product name 3B LASER PEN 200
Device type Low-level laser therapy device
Proper use Low-energy laser system for the treatment of pain, trigger, and acupuncture
points as well as small skin areas

Last revised 2017-11-08 20
Weight Applicator: approx
. 200 g
Charging station: approx . 230 g
Housing Plastic/ABS
Manufacturer
Name of manufacturer livetec GmbH, Marie-Curie-Str . 8, 79539 Lörrach, Germany
Conformity CE 0197
WEEE reg . no. FE 59335168
Sold by
3B Scientific GmbH, Rudorffweg 8, 21031 Hamburg, Germany
Phone: [phone]
Fax: [phone]
e-mail: [email protected]
Internet : www.3b-laser.de
American 3B Scientific
2189 Flintstone Dr, Suite
Tucker, GA 30084
USA
Tel: [phone]
Cell: +1.770.310.5886
Fax: [phone]