MeDioStar

USER MANUAL
Copyright

Knowledge of this manual is required for the operation of the instrument. Therefore please make
yourself familiar with the contents of this manual and pay special attention to hints concerning the
safe operation of the instrument.

The specifications are subject to change; the manual is not covered by an update service.

© Unless expressly authorized, forwarding and duplication of this document, and the
utilization and communication of its contents are not permitted. Violations will entail
an obligation to pay compensation.
All rights reserved in the event of granting of patents or registration of a utility
model.

1530 99 005_5 – 1007

Content

1 INTENDED USE ................................................................

................................................................................................
.........................................................................
.........................................1
2 TECHNICAL DATA ................................................................
................................................................................................
....................................................................
....................................3
3 SAFETY NOTES ................................................................
................................................................................................
.........................................................................
.........................................5
4 START<
START<UP ................................................................
................................................................................................
..............................................................................
..............................................10
4.1 Check for completeness ................................................................
................................................................................................
.................................................................
................................. 10
4.2 Installation ................................................................
................................................................................................
.....................................................................................
..................................................... 12
4.2.1 Installation of basic device ........................................................................................ 13
4.2.2 Connection to power outlet ...................................................................................... 13
4.2.3 Note on installation................................................................................................... 14
4.2.4 Connection of warning lamp and door interlock ....................................................... 14
4.3 Preparations for use ................................................................
................................................................................................
.......................................................................
....................................... 15
4.4 Switching ON ................................................................
................................................................................................
................................................................................
................................................ 16
4.5 Checking the beam delivery system ................................................................
...............................................................................
............................................... 16
4.6 Operation ................................................................
................................................................................................
......................................................................................
...................................................... 18
4.6.1 Adjustment of treatment parameters ........................................................................ 19
4.6.2 Adjustment of spot size ............................................................................................. 19
4.6.3 Memory Keys STORE/ RECALL................................................................................. 20
4.6.4 Use of skin cooling device ......................................................................................... 21
4.6.5 Treatment ................................................................................................................. 22
4.6.5.1 Making the laser operational ............................................................................. 22
4.6.5.2 Releasing the treatment beam ........................................................................... 23
4.6.5.3 Logging of treatment parameters and finishing the laser session ........................ 24
4.6.6 Special functions (TOOLS) ........................................................................................ 24
4.6.7 Professional Mode .................................................................................................... 26
4.6.8 Vascular Mode (with Vascular Upgrade only) ........................................................... 27
5 CLEANING AND DISINFECTION
DISINFECTION ................................................................
.............................................................................
.............................................28
Optical fiber ........................................................................................................................ 29
6 ACCESSORIES ................................................................
................................................................................................
........................................................................
........................................30
7 ERROR MESSAGES ................................................................
................................................................................................
.................................................................
.................................31
8 CALIBRATION PROCEDURE
PROCEDURE ................................................................
...................................................................................
...................................................32

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Content

9 TECHNICAL SERVICE
SERVICE ................................................................
..............................................................................................
..............................................................33
10 WARNINGS ................................................................
................................................................................................
............................................................................
............................................34
11 LABELS ................................................................
................................................................................................
...................................................................................
...................................................35
12 REGULAR SAFETY CHECKS
CHECKS AND CALIBRATION.....................................................
.....................................................40
Frequency of safety checks .................................................................................................. 40
Wear parts of safety checks yearly ....................................................................................... 41
13 DISPOSAL ................................................................
................................................................................................
..............................................................................
..............................................41
ANNEX: EMC Guidance and Manufacturer’s Declaration 42

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Intended Use

1 Intended Use
The MeDioStar is a pulsed diode laser (Class 4 laser product) that is used for the removal of
[1] [1][2]
undesired hair, the treatment of Acne , for the treatment of vascular lesions and for Skin
[1][3]
Rejuvenation . The melanin and blood rather strongly absorb the radiation of the
wavelength emitted by this laser, whereas the absorption of the surrounding is relatively low.
In this way, the radiation destroys the target structure while protecting the normal skin.
As a medical laser designed for this field of application the device features compactness,
largely maintenance<free operation and long service life.
In designing the MeDioStar, a new powerful medical laser device, Asclepion Laser
Technologies GmbH made use of its long<standing experience in the manufacture of medical
lasers.
The MeDioStar is a reliable, compact laser device that features extreme simplicity of
operation and that can be used in any private practice or clinic.
The device is easily relocated to the desired place of treatment.
The MeDioStar fully complies with the requirements of the Medical Product Law. It is
designed to the generally accepted rules of technology and meets all relevant safety
standards.

It must expressly be pointed out here, that the device may only be operated by persons
who received introductory instructions on its use. This must be confirmed by signature in
the medical device logbook. In addition, the user must have read this user manual and
the application manual.
The initial introduction into the operation of the device will be given by persons
employed with or trained by Asclepion Laser Technologies GmbH during the installation
procedure.
Active medical devices may be used only by persons who can ensure proper handling
because of their qualification and practical experience.
Specialist training courses are offered, among others, also by Asclepion Laser
Technologies GmbH.
Non<
Non<observance of the instructions given may result in risks to the health of patients and
operator as well as damage to the device! The manufacturer will not assume any liability
for such damage.

[1]
NOT FOR SALE IN USA
[2]
with Vascular Upgrade only
[3]
Skin Rejuvenation can in general be understood as improvement of the skin texture (skin tightening,
reducing of size of pores), skin whitening (lightening of pigmentation) and reducing of fine wrinkles
< the whole appearance is rejuvenated.

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Intended Use

Medical Device Directive

The MeDioStar meets the requirements of the EC Medical Device Directive
93/42/EEC and of their national equivalent in form of the German Medical
Product Act (MPG)
Instrument class according to the MPG: II b
UMDNS<No.: 16<948

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Technical Data

2 Technical Data

Device models:
Model Model no. Built-in laser modules
MeDioStar XT 1530 Diode modul 808nm
MeDioStar miXT 810 1531 Diode modul 75% 808nm and 25% 938nm
MeDioStar miXT 940 1532 Diode modul 75% 938nm and 25% 808nm
The basic unit is identical for all device models, the models only differ in the the type of built<in laser
modules. The models can be identified by the Model Number specified on the type label on the rear
panel of the device (see 10. Labels).

Laser type: High<power laser diode array

Laser class: 4
Required laser safety goggles MeDioStar XT: D (810 ± 15) nm L5
(acc. to EN 207: 2002) MeDioStar miXT 810: D (810 ± 15) and (940 ± 15) nm L5
MeDioStar miXT 940: D (810 ± 15) and (940 ± 15) nm L5
Wavelength: MeDioStar XT : 808 nm
MeDioStar miXT 810: 75% 808nm + 25% 938nm
MeDioStar miXT 940: 75% 938nm + 25% 808nm
Pulse length: Basic Mode: 190 ms double pulse with break
Professional Mode: max. 500ms single/ double pulse
Vascular Mode: max. 200 ms single pulse (NOT FOR SALE IN USA)
Pulse energy: Max. 50 J
Spot size: 4, 6, 10, 12 AND 14 mm; Slit (0.28cm²)
Pulse frequency: 0.5 Hz, 1 Hz, 1.5 Hz, 2 Hz, 3 Hz and 4 Hz
Tolerance
Tolerance of output power: Max. 20%
Laser beam mode: Multimode
Laser beam size: Max. 14 mm
Laser beam dive:rgence Max. 350 mrad (full angle, 1/e²)
Nominal Ocular Hazard
Distance (NOHD) with handpiece: 26 m

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Technical Data
Aiming laser: Diode
Wavelength: 635 nm
Power: <1 mW; adjustable intensity
Laser class: 1
Spot size: Max. 14 mm
Divergence: Max. 350 mrad (full angle, 1/e²)
Beam delivery: Optical fiber with handpiece
Display: LCD colour display
Operator guidance: Touch screen, jog dial
Power requirements: 100/120/208/230/240 VAC, internally reversible, 50/60 Hz
Rated current: Max.8A at 208/ 230/ 240V, max.12A at 100/ 120V
Skin cooling: Integrated cooling by Peltier elements
Dimensions: 365 x 600 x 975 mm³ (W x D x H)
Weight: 90 kg
Environmental
Environmental requirements: Temperature: 15°C up to 28°C, rel. humidity: ≤ 85%
Door contact supply: 5 V / 10 mA
Laser warning lamp: Floating relay contact max. 24 V / 1,0 A
Transport and
Storage conditions:
conditions: Temperature: 0°C up to +70°C (32°F up to 158°F)
Rel. humidity: 10 % ... 95 % (no condensation)
Mechanical loads: as per Class 2M1 IEC 721 Part 3<2

Enclosure Protection: IP 20 (no protection against entry of water)

Protection Class I (protection against electrical shocks)

Device Type B
Medical Device Class II b (EC Medical Device Directive 93/42/EEC).
Usage: The device is designed for continuous operation.
Accessories: See chapter 6

1530 99 005_5 – 1007 4

Safety Notes

3 Safety Notes
In this manual, the following symbols are used to refer you to dangers or notes on
operation.

Risk of accidents or physical injury.

Risk of possible technical damage.

The MeDioStar complies with the EC Medical Device Directive (93/42/EEC).

Please observe any relevant national
national regulations !
The above directives bind the owner/operator, the authorized persons and users of Class
IIb devices to take a number of precautions. In particular, such devices may be operated
only in accordance with the generally accepted rules of technology and the relevant
regulations on labour safety and the prevention of accidents.
In handling medical laser devices observe the currently binding version of the relevant
regulations on the prevention of accidents by laser exposure.
You are committed to keep a medical device logbook, which is enclosed to the folder for
documents. Our service technician will assist you in filling it in as part of the start<up
procedure.

Please make sure to have this device checked annually for technical safety.
safety. The results of
these safety checks must be documented in the medical device logbook. These safety
checks are provided by the Asclepion Laser Technologies GmbH.

Do not install the Laser in explosion<

explosion<risk areas.

The device may only be serviced, repaired or modified by persons employed with or
authorized by Asclepion Laser Technologies GmbH.

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Safety Notes

The regulations for the prevention of accidents by laser radiation IEC 60 825 –1 /
EN 60 825<
825<1 (or national requirements)
requirements) lay down general rules for the protection against
hazardous laser exposure. In the context of medical application, they aim to protect
operating personnel and patients during laser operation. The laser devices are classified in
different classes depending on the potential risks involved. The MeDioStar is classified in
Class 4.

This means that improper use of the device may cause risks to the eyes by direct or
scattered laser radiation. Besides, laser radiation may cause fire and explosion.
explosion.

To avert these risks, the owner/operator is obliged to comply among others with the
following requirements:

• Prior to initial start<up, the intended use of the laser must be notified to the competent
Professional Association and the labour<safety authority ( see national requirements).

• A laser safety officer must be appointed in writing. The minimum responsibilities of the
laser safety officer include:
⇒ Supervision of the operation of the laser device
⇒ Assistance to the owner/operator to ensure safe operation and implement
the necessary precautions
⇒ Co<operation with labour safety specialists in fulfilling their tasks, including
information about important issues of the protection against laser radiation
(see national requirements).

• While the laser is in use, the area in which the maximum permissible radiation level may
be exceeded, the so<called "laser area", must be delimited and marked by a laser
warning sign. Warning lamps at the entrances must indicate operation of the laser
(see national requirements).
Every laser system supplied by the manufacturer comes with an additional laser warning
sign. We recommend affixing this sign (see figure) at the entrance to the laser treatment
room to warn the persons entering of the installed laser device.

Fig. 1: Laser warning sign at laser room entrance

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Safety Notes

• The value of the NOHD (Nominal Ocular Hazard Distance) is so high, that the whole
treatment room, where the laser is used, is defined as laser area.

• Personal eye protection: All persons present in the laser area must wear laser safety
goggles. The safety goggles must provide at least a protection level that is specified in
the technical data.

Laser<
Laser<induced fire hazard

Do not install this device in explosion

explosion<
losion<risk areas. Before using the laser device, allow for the
evaporation of solvents and flammable solutions used for cleaning and disinfection.

When the laser beam strikes the surface of an object, the surface will absorb the laser
energy thus causing the surface temperature to rise, irrespective of whether it is skin, hair,
clothes or any other flammable substance. The operators should take the following safety
precautions to prevent laser<induced fire:
< Use non<flammable substances for anesthesia, for the preparation of soft tissue for
treatment, and for the cleaning and disinfection of instruments.
< Be especially careful when using oxygen. Oxygen will increase both the severity and
the extent of fire.
< Keep only a minimum of combustible materials in the treatment room. If treatment
requires the use of combustible material, such as gauze, soak it in water first.
< Keep clothes away of the treatment area as far as possible.
< Prevent singeing or burning when treating an area with hair by wetting the area with
water or saline before beginning treatment.
< Always keep a small fire extinguisher and water at hand in the treatment room.
< Avoid the use of flammable anesthetics or oxidizing gases, such as nitrous oxide (N2O)
and oxygen.
< When saturated with oxygen, some materials, such as cotton wool, may be ignited by
the high temperatures produced in normal use of the laser equipment.
< Before using the laser, allow the solvents of adhesives and flammable solutions used for
cleaning and disinfection to be evaporated. Also, take into consideration that
endogenous gases may be ignited by laser light.

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Safety Notes

Electrical hazards
The laser uses line voltage and high voltage. Never open any protective covers if you are
neither trained nor authorized to do so.

Never place any liquids onto the device as liquid entering the device might reduce the
pro
pr otection against hazardous electric voltages. If liquids got into the device, instantly switch
the device off with the Laser STOP button and disconnect the power cable. Then, please
contact Technical Service.

Radio frequency interference

The laser complies with the requirements of the EN 60601<1<2 standard. The system is not
affected by electromagnetic noise generated by other devices that conform to the same
standard. In addition, the system does not generate electromagnetic noise in compliance
with EN 60601<1<2.

Medical devices are subject to particular precautions in respect to the electromagnetic

compatibility (EMC). Please pay attention by installation
installation and operation of the laser de
device
to the special notes given in the accompanying documentation under "EMC
Manufacturer’s Dec
Declaration".

Portable and mobile HF – communication devices may effect medical electrical devices.
Cellulars
Ce llulars and similar devices have to be switched off before commissioning of the laser
device.

Safety features of the device

Numerous precautions have been taken to provide a high level of active safety in combination
with high operating convenience:

• Immediately on turning on the device, the microprocessor control performs a self<test.

• Following this test, a number of safety<related components are automatically tested.

• The device switches to Standby mode. The device will display an error message if the
device failed to successfully pass this test.

• While the laser is in use, the microprocessor control is continuously being checked for
proper function.

• Highest priority has been given to preventing any risk to the physician and the patient
as a result of a component failure.

• The device is fitted with lockable castors. These castors must be locked again after any
relocation of the device to secure it against any unwanted movement.

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Safety Notes

Additional information
Upon request, the manufacturer will provide circuit diagrams, component parts lists,
descriptions, calibration instructions, or other information not yet contained in this user
manual to assist appropriately qualified technical staff to repair those parts of the device
that have been designated by the manufacturer as repairable. “Appropriately qualified
technical staff” in this context means staff that attended a manufacturer’s service training
course on this device and that were authorized to repair it.

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Start-up

4 Start<
Start<up
Initial installation of the MeDioStar is always performed by an authorized representative of
Asclepion Laser Technologies GmbH. Based on the instructions of this manual the
representative will explain the responsible operator how to operate the laser device.

4.1. Check for completeness

Verify that all components required for safe operation of the laser device are present.

• Basic unit

• Power cable

• Footswitch

• Beam delivery fibre and handpieces

• Warning lamp / door interlock connector

• Safety goggles acc. to chapter Technical Data (number according to order)

• Documents

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Start-up

Laser fiber coupling

Laser aperture

Handpiece incl.
skin cooling device KRYO

Cooling unit

Fig. 2: Front view of MeDioStar

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Start-up

4.2. Installation
All major connectors are located at the rear panel of the device.

fiber holder

fiber coupling

fill level skin cooling

footswitch/
door interlock service interface

power switch

fuses

mains connection
potential
equalization

Fig. 3: Connections on the rare side of laser system

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Start-up

4.2.1. Installation of basic device

Absolutely make sure to disconnect the power cable from the power outlet during
installation!

Installation of the basic unit is very simple and should best be performed in the following
order (see figure):
1. Mount the fiber holder in the front of the device
2. Mount the handpiece holder on the fiber holder
3. Connect the coolant interface as illustrated by means of the two quick<lock couplings.
4. Establish the electric connections between the socket as illustrated by using the cable from
the handpiece.
5. Connect the laser fiber plug and fix the outer ring.
6. Mount the laser and cooling fiber inside of the top point of the fiber holder and place the
handpiece in the holder
7. Close the Connection port by using the small white cover
8. Connect the footswitch and door interlock
9. Connect the power cable
Now, the installation of the basic unit is concluded. Next, you can continue with the start<up
procedure.

4.2.2. Connection to power outlet

Connect the laser device to a single<phase power outlet protected by a slow<blow (type C)
fuse of 10 A for 208/230/240 VAC or 16 A for 100/120 VAC.
Confirm the local power outlet with the line voltage
voltage of the MeDioStar on the back side of
the device!
The switched line voltage of the MeDioStar is available on the Certification / Identification
label. Other Voltage’s (see section 2) can be selected inside of the device. Please ask your
local distributor for this option.

When choosing the internal voltage selector consider all technical data of local mains and
the device (see section 2). Make sure that the internal voltage selector of the device is
correctly set and the voltage option on the identification label is crossed.
This is only allowed persons employed with or authorized by Asclepion Laser
Technologies GmbH.
Please observe the requirements of IEC 64, respectively national requirements in valid
version.
If the switched voltage does not conform with you local mains all electronic components
inside of the device could be damaged! In this case you will lose all warranty claims!

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Start-up

4.2.3. Note on installation

Keep a free space of at least 15 cm to the wall to ensure the necessary efficiency of the
cooling system. For service work, it should be possible to have a free space of 80 cm around
the device.

4.2.4. Connection of warning lamp and door interlock / Service

In addition to the prescribed warning signs, every entrance to the

the laser area (typically the
laser treatment room) must be equipped with warning lamps that are lighting (or flashing)
as long as the laser emits radiation.

When connecting a warning lamp and an external transformer the user is install installing
ing a
device system, according to IEC 60601<
60601<1<1 and is potentially influencing the approved
isolation system. Therefore only safety transformer with strengthened isolation with a
minimal testing of 4 kV according to IEC/EN61558<
IEC/EN61558<2<6 must be used. Although it it has to
be granted, that the leakage current of the machine after connecting the transformer,
fulfils the specification according to IEC<
IEC<60601<
60601<1.

On the rear panel of the device, a connector is provided for the connection of a door
interlock and a warning lamp (refer to Fig. 3). If you do not use these safety devices, make
sure to plug the door<interlock plug provided into this connector.

Relay contact for laser emission warning lamp

Door interlock

Fig. 4: Connectors for door interlock and laser warning lamp

If the two "door interlock 5VDC/10 mA" terminals are connected to an external contact,
such as a door interlock, you can prevent laser radiation from being emitted when the door is
being opened.
During laser operation, the surgical beam will instantly be switched off when the door is
opened thus precluding any risk to the person entering.
This external circuit must not get in touch with a mains conductor and not be accommodated
in a connector or any other connecting element carrying line voltage. To be able to operate
the laser, this contact must be closed.

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Start-up

The door<interlock connector provided is therefore factory<fitted with a shorting bridge. For
connection of a door<interlock circuit, remove this bridge and connect your door interlock to
the same terminals.
If you do not use a door<interlock circuit, make sure to keep the connector with shorting
bridge connected. The same connector provides connection to a floating normally open
contact. This contact allows a circuit for a low<voltage warning lamp to be switched (max.
24V / 1A). The contact closes when the laser is switched to ‘READY’<mode.
The prescribed laser warning lamp may, of course, also be installed completely separately
from the laser device and turned on and off via a normal light switch.
Service interface / I²C connector (USB)
Both connectors at the back of the device are used for service only by persons employed
with or authorized by Asclepion Laser Technologies GmbH and must not at all be combined
to any other device, otherwise irreparable damages are possible.

4.3. Preparations for use

After every relocation of the device from a colder to a warmer environment with a
temperature difference of more than 5°C (41°F), let the device in unpacked condition
adjust to room temperature for the following periods :
min. 2 hours at a temperature difference of up to 10°C (50 °F)
min. 4 hours at a temperature difference of up to 15°C (59°F)
min. 10 hours at a temperature difference of more than 15°C (59 °F)
Non<
Non<observance of this instruction may destroy the device.

Make sure the following requirements have been met:

1. Voltage selector on the identification label conform to the local line voltage.
2. Optical fiber with handpiece have been connected.
3. Power plug of device has been connected to an appropriate power outlet. The main
switch has been set to ON.

The end of the fiber bundle (direction to the device) has to be checked for cleanness, each
kind of dirty has to be removed (with moist, smoth pad, alcohol or isopropanol is also
possible – than surface has to be polished dry) .
Each absorbent contamination generate a local overheating and might be lead damages at
the device!

4. Footswitch has been connected (when requested).

5. Warning lamp has been installed at the entrance (when requested).
6. Safety door interlock has been connected (when requested).

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Start-up

4.4. Switching ON
Insert the safety key into the key switch and turn it clockwise as far as it will go.
The system will perform a self<test to check the essential and safety<relevant components of
the device for proper function.
After some seconds, the basic menu will appear on the screen and guide you through further
operation (refer to Fig. 5). It will take about 5 seconds for the self<test to finish. Only then
the keys will be activated.
The device is in ‘STANDBY’<mode and displays all parameters adjustable.

4.5. Checking the beam delivery system

For checking the beam delivery system must be put on the enclosed safety goggles !

1. The beam delivery system consists of the optical fiber and the handpiece.
2. An aiming beam was integrated in the MeDioStar in order to check the beam delivery
system. The aiming beam transmits the same optical path through the beam delivery
system as the surgical beam. It is switched ON only in ‘STANDBY’<mode. If the aiming
beam does not evenly illuminate the beam exit aperture of the handpiece, this may
indicate that the beam delivery system is either damaged or misaligned.
3. The red aiming spot should be regarded with the installation of the device in order to be
able to assess any later modifications.

If the aiming laser does not evenly illuminate the beam exit aperture of the handpiece or
the optical fiber, do not activate the surgical beam to avoid local overheatings,
overtreatments or damage to the device!
In this case the handpiece tip has to be replaced.
You can only assess the evenness of illumination in ‘STANDBY’<
‘STANDBY’<mode, as the aiming laser
is on only in this mode!
‘READY’<<mode to prevent unintentional
This check can and must never be performed in ‘READY’ unintentional
release of the surgical laser beam!

Make absolutely sure that the distal end of the handpiece keep cleaned. Each absorbent
contamination generate a local overheating and might be lead to overtreatments and
damages at the handpiece!
handpiece!

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Start-up

fibre holder

emission indicator

display with touch screen

jog dial

key switch

emergency switch

Fig. 5: Controls

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Start-up

4.6. Operation

The use of controls or adjustments or performance

performance of procedures other than those
specified in this manual may result in hazardous laser radiation exposure.

The following treatment modes are available:

BASIC mode
PROFESSIONAL mode
VASCULAR mode (optional, not for sale in USA)

Switching between the available modes is by pressing the top key .

On completion of the start<up routine, the display shows the menu of the treatment mode
used last.

On completion of the start<up routine, the display shows following the menu (Basic mode).

Fig. 6: Display BASIC (STANDBY)

Operation of the device via the touch screen and Jog Dial is very simple and self<explanatory.
The system will respond to every successful key pressure by a short beep.

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Start-up

4.6.1. Adjustment
Adjustment of treatment parameters
The parameters, which have to be changed (FLUENCE, SPEED or TIME) are activated for change by
pressing the numerical field at the display. Then these values are changed by turning the jog dial.
Afterwards the new numbers have to store by pressing the numerical field once more (or by pressing
the jog dial), otherwise the old parameter is activated.
The energy density is the crucial parameter for laser treatment. It is displayed as FLUENCE in J/cm².
If the energy range is not sufficient to achieve the desired fluence value, replace the used beam tip
by one having a smaller diameter. Tip detection and recalculation of the new fluence value is
automatic.
If within the FLUENCE field a small triangle appears, the energy has slightly increased (arrowhead
pointing upward) or decreased (arrowhead pointing downward) within the tolerance limits. These
slight variations can be compensated for, if necessary, by slightly readjusting the fluence.
The pulse frequency is adjustable in the SPEED field. The following frequencies are selectable:
0.5 Hz, 1 Hz, 1.5 Hz, 2 Hz, 3 Hz and 4 Hz (dependent on adjusted fluence).

4.6.2. Adjustment of spot size

On the MeDioStar, the laser spot size can be varied by changing of the handpiece tip. The system
automatically detects any variation and considers it accordingly. The currently selected spot size is
displayed.

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Start-up

4.6.3. Memory Keys STORE/ RECALL

These 2 keys are memory keys for free program storage/ recall. For storage first the new
parameters has to be adjusted at the display.
They provide the storage / recall of individual treatment parameters by shortly pressing the
respective key, which shows then the Jog Dial sign. By turning of the Jog Dial you can
choose your favorite memory field from M1 to M10, the display than shows the actual
parameters of this special memory. By pressing the Jog Dial or the STORE< / RECALL< key
you have to confirm the chosen parameter, otherwise the system will go back to the old
settings.

(first to set the new parameters)

STORE RECALL

turning
turning
Jog Dial
Jog Dial

Press Jog Dial or STORE / RECALL key to confirm

Fig. 7: Memory Keys

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Start-up

4.6.4. Use of skin cooling device

After switching on of the MeDioStar it is necessary to check, that the temperature of the
cooling
coolin g tip runs from room temperature to the setting +4°C within 180 sec. Therefore the
software start a screen “Cool Down Handpiece” with a running bar. The screen will
leave, if the cool tip has reached an temperature about +8°C. The nominal value of +4°C
will
will be reached in the next 20 sec. The same for activating the device after 15 min of non
using.
If the screen “Cool Down Handpiece” will not leave after 180 sec it seems to be a
distributor.
malfunction in the cooling device. Please contact in this case your local dist ributor.
It’s normal, that the temperature rises some degrees by moving the cold probe from one
warm skin area to the next – what is necessary for the treatment. If the temperature
comes to the upper limit, the screen “Cool Down Handpiece” will be shown. After After
leaving this screen, the treatment can be to continue.
As the cooling surface of the skin<
skin<cooling device is made of aluminium, sensitive persons
may respond to its application with allergic skin reactions.

The skin<
skin<cooling device eemploys
mploys the Peltier effect and serves for cooling the skin directly
before the application of the next laser pulse.
Cooling is performed by close contact of the skin with the cold metal probe. Therefore the
cold Aluminium probe has to keep in close contact to the skin during treatment.

Fig. 8: Handpiece MeDioStar

1530 99 005_5 – 1007 21

Start-up

4.6.5. Treatment

4.6.5.1. Making the laser operational

Prior to pushing the READY key, the attending physician must verify that all persons
present in the laser room wear laser protective eyewear of at least a protection level that
is specified in the chapter Technical Data

• When the READY key has been pressed, the laser is ready for operation. Radiation of the
displayed parameters will be emitted by either pressing the handpiece onto the skin by
pressing the footswitch.

• After the spot size and colour code of the active tip has briefly flashed on the display, the
laser warning sign appears above the READY field (refer to Fig 8).

• Whenever you change a parameter in READY mode, the device will automatically return
to STANDBY mode. In this case, press the READY key again to reactivate the READY
mode.

• Place the handpiece onto the desired treatment area.

Note that in READY mode a laser pulse will be fired when you accidentally release the
footswitch!

• While laser radiation is being emitted, the laser emission indicator beside the display is
lighting. Additionally, an audible signal is being generated at the frequency adjusted for
the treatment beam.
If you intend to interrupt the treatment for some time, press the READY key again to switch
the laser to the safe STANDBY mode. In this mode, it is impossible to release emission
unintentionally.

1530 99 005_5 – 1007 22

Start-up

Fig. 9: Display BASIC (Laser READY)

4.6.5.2. Releasing the treatment beam

On release by footswitch, Class 4 laser radiation will be emitted from the end of the
handpiece. Make sure to comply with all relevant regulations for the protection against
unintentional laser radiation effects.

In particular,
particular, the attending physician is not allowed to release the laser un
unless the aiming
beam spot was found to be perfect and the handpiece was placed directly onto the skin
area to be treated.

The adjusted fluence has to be checked for correctness

correctness regularly.
dan
Instantly press the EMERGENCY STOP pushbutton in the event of da ngerous
malfunction.
Take care to keep the distal end of the handpiece clean! Any contamination absorbing
laser light will cause local overheating and thus may lead to defects at the handpiece and
excess treatment!

To release the surgical laser beam with the pre<selected parameters, press the foot switch.
In treatment breaks or on completion of a treatment session, press the READY key again to
switch the laser to the STANDBY mode. In this mode, unintentional release of laser radiation
is impossible.
If you do not press any key, or footswitch for more than five minutes, the MeDioStar will
automatically switch some suppliers off.

1530 99 005_5 – 1007 23

Start-up

4.6.5.3. Logging of treatment parameters

parameters and finishing the laser session
In the ‘TOOLS’<menu that is accessible via the ‘TOOLS’<key, the total number of emitted
pulses and the pulses emitted after the last ‘RESET’<action is displayed.
Prior to the treatment of the next patient, you can reset the pulse count to zero by pressing
the ‘RESET’ key (3 sec.).
Shut down the laser by turning the key switch anti<clockwise. In doing this, the system
automatically performs a ‘RESET’.

After you have shut down the laser, absolutely make sure to remove the key and keep it in
a safe place to prevent unauthorized use of the device.

Switch off the instrument by power switch on the rear side.

Suspend the handpiece safely and check the beam exit face of the handpiece for
contamination. Contaminated beam exit faces must be cleaned immediately.

4.6.6. Special functions (TOOLS)

Press the ‘TOOLS’<key to activate the ‘TOOLS’<menu (refer to Fig 9).
In this menu, the total number of emitted pulses and the pulses emitted after the last
‘RESET’<action is displayed.
In addition, the ‘TOOLS’<menu provides keys for the following functions:

pulse counter
• reset current
Resets the current puls count on the display to zero.
• current
Show the current puls counter.
• total
Show the total puls counter.

1530 99 005_5 – 1007 24

Start-up

display
• brightness
brightness
Adjustment of the display brightness.
• SW
Installed display software version.

special
• pilot
Adjustment of the pilot brightness.
• unlock mode – for service only

ENERGY
On pressing this key, the basic menu additionally includes display of laser energy and spot
size.

RETURN
Pressing this key stores the current settings of the TOOLS menu and returns to the basic
menu.

Fig. 10:
10: Display (TOOLS)

1530 99 005_5 – 1007 25

Start-up

4.6.7. Professional Mode

The PROFESSIONAL<mode allows to adjust the pulse length (TIME) individually. Par example it is
possible to set the pulse length very long even at low fluences, this is recommendable for dark skin
types.

The use of controls or adjustments or performance of procedures other than those

specified in this manual may result in hazardous laser radiation exposure.

In this mode, the screen looks as follows:

Fig. 11:
11: Display PROFESSIONAL (In STANDBY)

Adjustment of treatment parameters

In contrast to the BASIC mode, in this mode you can additionally adjust the pulse duration of single/
double pulse within defined limits in the TIME field. The fluence is kept constant (within the defined
limits).
The maximal frequency in PROFESSIONAL mode is 2Hz.

1530 99 005_5 – 1007 26

Start-up

4.6.8. Vascular Mode (with Vascular Upgrade only)

In Vascular mode the pulse is applied as a single pulse with a max. pulse length about 200 ms. The
maximum fluence is much more higher than in the other modes, it is max. 170J/cm².
Operation of the device is identical with that in PROFESSIONAL mode except for some parametric
restrictions.

Fig. 12:
12: Display VASCULAR (In STANDBY)

1530 99 005_5 – 1007 27

Cleaning and disinfection

5. Cleaning and disinfection

Handpiece
The distal optical surfaces of the handpiece are largely protected against contamination by the
treatment technique recommended (refer to the Application Manual). Despite of this, you should
check them also during treatment and clean them, if necessary, with a clean, lintless, moistened
cloth. You may also use alcohol or isopropyl alcohol, if necessary.

Dirt on optical surfaces will burn in by laser radiation and lead to malfunction and
overtreatments!

Make sure to switch the laser to ‘STANDBY’ before you start cleaning!
If you use alcohol or isopropyl alcohol, do not clean
clean near the treatment area to avoid the
risk of fire.

The tipp of the handpiece may easily be removed from the rest of the handpiece. Take care to make
the handpieces complete again after cleaning. Only then you are allowed to reactivate the laser.

After every treatment, clean distal glass components moistly (in ultrasonic cleaning
bath, if necessary) or with alcohol. Then carefully dry and disinfect them.

Use only the original Asclepion Laser Technologies cleaning

cleaning cloth to clean the glass
components, other sheets may damage the optical coating.

Cleaning of the interior parts of the rest of the handpiece is not necessary.

1530 99 005_5 – 1007 28

Cleaning and disinfection

Optical fiber
All optical components and the end faces of the optical fiber must be handled with extreme care and
protected from dust and contamination.

Prior to every removal of the beam delivery system, make sure to switch off the device!

General:

Prior to cleaning, disconnect the laser device from mains

mains by removing the power cable
from the power outlet.

You may clean all accessible surfaces of device components, beam delivery system and handpieces
with a soft, slightly moistened cloth. We recommend to use NEVER a fully wet or even dripping
cloth.
To remove sticking dirt, you may use a mild detergent or disinfectant.
Do not use any aggressive disinfectants or abrasives.

1530 99 005_5 – 1007 29

Accessories

6. Accessories

Please note that the EC Medical Device Directive (93/42/EEC) binds you to use only such
accessories that have been tested and approved and intended by Asclepion Laser
Technologies GmbH for the use in combination with this laser.
We strongly advise against the use of accessories from other manufacturers. Even if an
official testing authority has certified that
that a specific accessory unit can be used safely,
Asclepion Laser Technologies GmbH will not assume any liability for its use.

Order No.

4241 Handpiece tip MeDioStar 14 mm

4240 Handpiece tip MeDioStar 12mm
4239 Handpiece tip MeDioStar 10 mm
4242 Handpiece tip MeDioStar 6 mm
4238 Handpiece tip MeDioStar 4 mm
4237 Handpiece tip MeDioStar Slit

1222 Protective eyewear MeDioStar XT

1231 Protective eyewear MeDioStar miXT and MeDioStar XT

2931 Upgrade MeDioStar Vascular

1530 99 005_5 – 1007 30

Error Messages

7. Error Messages

• If the device does not respond to turning the key switch ON, make sure the following
requirements are met:
1. The ‘EMERGENCY STOP’<switch is unlocked. If not, turn the red knob of the push<
button anti<clockwise.
2. The main switch on the rear panel of the device is set to ON and the main fuses on
the rear panel are not blown. To check the fine<wire fuses, turn off the device.
3. As mentioned previously, you are guided in operating the laser and in fault finding
by microprocessor controlled prompts displayed on the screen.

Errors are indicated by the system as follows:

• The display shows an error message with instructions in plain text. The touch screen is
inoperative. Touching the screen will not generate a beep signal. The device will remain in
this state until you switch it off. Then, wait at least for 5 s before you restart the device. If
the error persists, call Technical Service.

You are strongly advised against any attempt to repair the device yourself! When you
remove device covers, highly dangerous high voltage generated in the device is accessible
and may be preserved even after the power cable was disconnected from the power
outlet!

• In the case of safety<relevant faults, the device switches off within milliseconds. In this
case, the display of error messages is impossible. If this should happen or any other fault
appear that is not described in this manual, switch off the device by disconnecting it from
power supply by unplugging the power plug from the power outlet.
In this case, please contact our Technical Service.

1530 99 005_5 – 1007 31

Calibration Procedure

8. Calibration Procedure

The device may only be serviced, repaired or modified by persons employed with or
authorized by Asclepion Laser Technologies GmbH.

Tools
Energy meter display (Ophir NOVA) Part No.: 660209022
Energy head (Ophir HE 1) Part No.: 660209027

Service Mode
To perform the Calibration Procedure it is necessary to activate the service mode.
If you need assistance, please contact the Technical Service (details see next chapter).

Preparations for energy

energy calibration:
Make the device ready for operation. Connect a 8mm, 10 mm, 12 mm or 14 mm tip to the
device. Fix the handpiece in front of the detector surface of the external energy<measuring
head about 2 ... 3 mm away from the beam exit surface of the handpiece. On the energy
meter, select a range of > 30 J.
Remove the cover of the laser unit and the lid of the energy<measuring unit located over the
high<power laser diode array.

During energy calibration, laser pulses are being emitted.

emitted. Make sure all persons present in
the laser room wear appropriate laser safety goggles !

By pressing OK, the starting menu of the energy calibration mode appears. At the same time,
the cooling system of the laser device is being switched on.
The menu for the energy calibration is exclusively accessible by pressing the
ENERGY ADJUST key at the bottom left. The key label changes to ADJUST OFFSET.
For calibration, always operate the device in single<shot mode.

• adjust offset/ gain channel A/ B

• adjust/ check
check energy adjustment

• safe energy adjustment, restart system

1530 99 005_5 – 1007 32

Technical Service

9. Technical Service

Never open the device and attempt to repair the device yourself if the laser should not
work properly.
The laser does not contain any user<
user<serviceable components.
components.
Only service technicians employed with or trained by Asclepion Laser Technologies GmbH
are authorized to service the device. This also applies to the prescribed annual safety
checks.

The energy delivered by the surgical laser must be

be checked at least annually by a service
technician employed with or trained and authorized by Asclepion Laser Technologies
GmbH.

If you need assistance by Technical Service, please contact :

Asclepion Laser Technologies GmbH

Service
Im Semmicht 1a
D<07751 JENA

Phone: +49 (0) 36 41/ 77 00 < 401

Fax: +49 (0) 36 41/ 77 00 – 402
e<mail: service@asclepion.com

Please note that the manufacturer, installer or importer will consider themselves responsible
for the effects of servicing on safety, reliability and performance of the device only if the
following requirements are met:

• Installation, extensions, readjustments, modifications or repairs have been performed by

authorized persons.

• The electric installation of the room meets the requirements of relevant IEC regulations.

• The device is used in accordance with the instructions of this manual.

1530 99 005_5 – 1007 33

Warnings

10. Warnings

Do not start up the device unless you have read this user manual.
Always keep the manual handy.

Portable and mobile HF – communication devices may effect medical electrical devices.
Cellulars and similar devices have to be switched off before commissioning of the laser
device.

Only specialists who are appropriately qualified and authorized by Asclepion

Asclepion Laser
Technologies are allowed to open the laser de
device.

All persons present in the laser room during laser operation must wear laser protective
eyewear appropriate for this type of laser and provided by the laser manufacturer.
Other laser protective eyewear possibly does not provide the degree of protection needed.

Even if you wear laser protective eyewear, never look directly into the laser exit aper
aperture of
the articulated arm or the handpiece.
handpiece.

on
Even if, due to a fault in the device, the device fails to fire a laser pulse o nce or several
times (skipped pulses), under no circumstances must you look into the distal end of the
handpiece, as the laser may fire further pul
pulses when you depress
depress the footswitch.

Make sure to switch the laser device into STANDBY mode, before you start cleaning it.
Never use any alcohol
alcohol or isopropyl alcohol near the treatment area to avoid the risk of fire.

The use of controls

controls or adjustments of the equipment for operation, maintenance, test
testing
and calibration or the performance of procedures other than those specified in this manual
may result in hazardous laser radiation ex
exposure.

Never place any liquids

liquids onto the device as liquid entering the device might reduce the
pro
pr otection against hazardous electric voltages. If liquids got into the device, instantly
switch the device off with the Laser STOP button and disconnect the power cable.
Immediately contact
contact Tech
Technical Service.

Never connect any other devices than released by Asclepion Laser Technologies to the
connectors accessible on the back panel of the la laser device. Never try to connect other
devices to the terminals. This could affect
affect the safety of the device and could lead to seri
serious
hazard for the patient and for the user. Additionally it could lead to a damage of the
device.

1530 99 005_5 – 1007 34

Labels

11. Labels
Various warning and information labels are affixed to the laser device .

Laser warning label Laser Warning label

Fig. 21 Fig.22

Interfaces
Fig. 26

Fuses MeDioStar
Certification/ Fig. 25
Identification label
Fig. 24
Potential equalization
Fig. 20
Attention
Fig. 23

Fig. 13:
13: Back view of MeDioStar

1530 99 005_5 – 1007 35

Labels

Laser Warning label

Fig. 15, 16, 17

Fig. 14:
14: Front view of MeDioStar

Warning label for the U.S.:

Laser aperture
Fig.18

Fig. 15:
15: View of MeDioStar handpiece

1530 99 005_5 – 1007 36

Labels

Fig. 16:
16: Laser aperture warning label Fig. 17:
17: Fiber with handpiece warning label
(not for US)

Fig. 18:
18: Laser aperture warning label (US) Fig. 19:
19: Laser aperture warning label at handpiece (US)
(US)

Fig. 20:
20: Potential equalization

1530 99 005_5 – 1007 37

Labels

Fig. 21:
21: Laser warning label MeDioStar XT Laser warning label MeDioStar miXT

Fig. 22:
22: Laser
Laser warning label MeDioStar XT Laser warning label MeDioStar miXT

1530 99 005_5 – 1007 38

 Labels

Fig. 23:
23: Attention: Observe accompanying documentation

Serial number

Voltage Version

Date of
manufacture
MM/YYYY

Application device
type B

Fig. 24:
24: Certification / Identification label MeDioStar

Fig. 25:
25: Fuses MeDioStar

Fig. 26:
26: Interfaces

1530 99 005_5 – 1007 39

Regular safety checks and calibration

12. Regular safety checks and calibration

calibration

Please note that the manufacturer recommends subjecting this device to regular safety
checks and calibration of the device at annual intervals. The results of these safety checks
must be documented in the medical device logbook.

Do not set up this device in explosion<

explosion<risk areas. Prior to using the laser device, allow for
the evaporation of solvents and flammable solutions used for cleaning and disinfection.

The device may only be serviced, repaired

repaired or modified by persons employed with or
authorized by Asclepion Laser Technologies GmbH.

Scope of safety checks

In compliance with the regulations laid down in national laws and EN 60 825
(or IEC 60 825) in the valid version the safety checks should at least include the following
tests:

• Earth leakage test under normal operating conditions

• Visual inspection of laser device and accessories

• Functional test

• Check for leakage on the device

• Measurement of actual output energy at handpiece

• Calibration of the device

• Test of earthing conductor connection

Frequency of safety checks

We recommend strongly to make at least one safety check by the year!

1530 99 005_5 – 1007 40

Disposal

Wear parts of safety checks yearly

• Filter candle F10<25µm

• Desiccator cartridge 68000

• Deionisation cartridge

Wear parts of safety checks additional every 2 years

• Deionised water

• Transmission laser fiber

Please note, that there is no longer warranty in case of reclamation against Asclepion Laser
Technologies GmbH, if there was no officially required safety check and calibration by
using the original spare parts / consumables.

Accessible Fuses (Fuse 5x20mm; 250 V):

• F1 T 6,3 A diode driver

• F2 T 2,5 A compressor

• F3 T 2,0 A pump

• F3 T 1,0 A solenoid valve

13. Disposal
The device must be disposed of in compliance with the regulations on electronic waste.
Please consult our Technical Service if you have any questions regarding disposal.

1530 99 005_5 – 1007 41

Annex: EMC

Annex: EMC Guidance and Manufacturer’s Declaration

Caution
The usage of others than the
the following accessories, transducers and cables may
result in an increased interference emission and/or decreased immunity of the
equipment and/ or system.

Accessory/ Title Item number Lenght / Dimensions

Laser handpiece 4235 00 000 < 3,0 m

Foot switch with cable 5501 99 021 < 3,0 m

Power cord 5507 04 013 < 3,0 m

1. Electromagnetic Emissions
The Device is suitable for use in the specified electromagnetic environment. The customer and/or
the user of the Device should assure that it is used in an electromagnetic environment as described
below:
Emissions Test Compliance Electromagnetic Environment
Guidance
RF emissions Group 1 The Device uses RF energy only for its
CISPR 11 internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions Class B
CISPR 11 The Device is suitable for use in all
establishments, including domestic
Harmonic emissions Class A establishments and those directly
IEC 61000<3<2 connected to the public low<
voltage power supply network that
Voltage fluctuations/ Complies
supplies buildings used for domestic
flicker emissions
purposes
IEC 61000<3<3

1530 99 005_5 – 1007 42

Annex: EMC

2. Electromagnetic Immunity
The Device is suitable for use in the specified electromagnetic environment. The customer and/or the
user of the Device should assure that it is used in an electromagnetic environment as described below:
Immunity Test IEC 60601<
60601<1<2 Compliance Level Electromagnetic Environment
Test Level Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete, or
discharge (ESD) ceramic tile. If floors are covered
with synthetic material, the relative
IEC 61000<4<2
± 8 kV air ± 8 kV air humidity should be at least 30 %.
Electrical fast ± 2 kV for power ± 2 kV Mains power quality should be that
transient/burst of a typical commercial and/or
hospital environment.
IEC 61000<4<4
± 1 kV for ± 1 kV
input/output lines
Surge ± 1 kV ± 1 kV Mains power quality should be that
differential mode of a typical commercial and/or
IEC 61000<4<5
hospital environment.
± 2 kV
± 2 kV
common mode
Voltage dips, short < 5 % <5% Mains power quality should be that
interruptions and UT for 0,5 cycle of a typical commercial and/or
voltage variations hospital environment. If the user of
(> 95 % dip)
on power supply the Device requires continued
input lines operation during power mains
40 % 40 %
interruptions, it is recommended
IEC 61000<4<11 UT for 5 cycles
that the Device be powered from an
(60 % dip) uninterruptible power supply or a
battery.
70 % 70 %
UT for 25 cycles
(30 % dip)

<5% <5%
UT for 5 sec
(> 95 % dip)
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of a
magnetic field typical location in a typical
commercial and/or hospital
IEC 61000<4<8
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

1530 99 005_5 – 1007 43

Annex: EMC

The Device is suitable for use in the specified electromagnetic environment. The customer and/or the user
of the Device should assure that it is used in an electromagnetic environment as described below:
Immunity Test IEC 60601<
60601<1<2 Compliance Electromagnetic Environment
Test Level Level Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Device, including cables, than
the recommended separation distance
calculated from the equation appropriate for
the frequency of the transmitter.
Recommended Separation Distance:
3,5
d= √P
V1

Conducted RF 3 Vrms 3V 3,5 80 MHz to

d= √P
IEC 61000<4<6 150 kHz to 80 MHz E1 800 MHz

Radiated RF 3 V/m 3 V/m 7 800 MHz to

d= √P
IEC 61000<4<3 80 MHz to 2,5 GHz E1 2,5 GHz

Where P is the maximum output power

rating of the transmitter in Watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).b
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
((( • )))

1530 99 005_5 – 1007 44

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

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

3. Recommended Seperation Distances

Recommended Seperation Distances between Portable and Mobile RF Communications Equipment

and the Device according to EN 60 601<1<2
Frequency of 150 kHz to 80 MHz 150 kHz to 800 MHz 800 MHz to 2,5 GHz
Transmitter
Equation d = [ 3,5 / V1 ] √P d = [ 3,5 / V1 ] √P d = [ 7 / E1 ] √P

Rated Maximum
Output Power of Seperation distance Seperation distance Seperation distance
Transmitter
(metres) (metres) (metres)
(Watts)
0,01 0,12 0,12 0,23
0,1 0,37 0,37 0,74
1 1,17 1,17 2,33
10 3,70 3,70 7,37
100 11,70 11,70 23,30
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power
rating of the transmitter in Watts (W) according to the transmitter manufacturer.
NOTE:These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

1530 99 005_5 – 1007 45